Page last updated: 2024-10-15

lutetium lu 177 dotatate

Description

177Lu-DOTA-octreotate: an somatostatin receptor agonist [Medical Subject Headings (MeSH), National Library of Medicine, extracted Dec-2023]

Cross-References

ID SourceID
PubMed CID132274234
MeSH IDM0415931

Synonyms (11)

Synonym
(177lu-dotaotyr3)octreotate
(177lutetium-dota(o)tyr3)octreotate
lu-dota-tate
177lu-dota-octreotate
lutetium lu 177 dotatate
lutetium (177lu) oxodotreotide
177lu-dota-tyr3-octreotate
ae221im3bb ,
unii-ae221im3bb
177lu-dotatate
lutathera

Toxicity

ExcerptReference
"Treatment with the combination of (177)Lu-octreotate and capecitabine was feasible and safe considering acute and subacute side effects."( Report on short-term side effects of treatments with 177Lu-octreotate in combination with capecitabine in seven patients with gastroenteropancreatic neuroendocrine tumours.
de Herder, WW; Kam, BL; Krenning, EP; Kwekkeboom, DJ; van Aken, MO; van Essen, M, 2008
)
" Serious adverse events that were likely attributable to the treatment were myelodysplastic syndrome in three patients, and temporary, nonfatal, liver toxicity in two patients."( Treatment with the radiolabeled somatostatin analog [177 Lu-DOTA 0,Tyr3]octreotate: toxicity, efficacy, and survival.
de Herder, WW; Feelders, RA; Kam, BL; Kooij, PP; Krenning, EP; Kwekkeboom, DJ; van Aken, MO; van Eijck, CH; van Essen, M, 2008
)
"Treatment with [(177)Lu-DOTA(0),Tyr(3)]octreotate has few adverse effects."( Treatment with the radiolabeled somatostatin analog [177 Lu-DOTA 0,Tyr3]octreotate: toxicity, efficacy, and survival.
de Herder, WW; Feelders, RA; Kam, BL; Kooij, PP; Krenning, EP; Kwekkeboom, DJ; van Aken, MO; van Eijck, CH; van Essen, M, 2008
)
" No serious acute or remote adverse events were recorded."( Renal and hematological toxicity in patients of neuroendocrine tumors after peptide receptor radionuclide therapy with 177Lu-DOTATATE.
Bal, C; Gupta, SK; Singla, S, 2012
)
" This provides further evidence that this is a safe and efficacious form of treatment for patients with progressive metastatic neuroendocrine tumours."( Early efficacy of and toxicity from lutetium-177-DOTATATE treatment in patients with progressive metastatic NET.
Caplin, M; Navalkissoor, S; Pencharz, D; Quigley, AM; Toumpanakis, C; Walker, M; Yalchin, M, 2017
)
"Peptide receptor radionuclide therapy (PRRT) with lutetium-177 (Lu)-DOTATATE is regarded as a safe treatment option with promising results for patients with neuroendocrine neoplasia (NEN)."( Peptide receptor radionuclide therapy with 177Lu-DOTA-octreotate: dosimetry, nephrotoxicity, and the effect of hematological toxicity on survival.
Heuschkel, M; Krause, BJ; Kurth, J; Löser, A; Schwarzenböck, SM; Willenberg, HS, 2018
)
" No severe subacute renal or hematological toxicity occurred (one Common Terminology Criteria for Adverse Events-grade 3 for thrombocytopenia and another one for leukocytopenia)."( Peptide receptor radionuclide therapy with 177Lu-DOTA-octreotate: dosimetry, nephrotoxicity, and the effect of hematological toxicity on survival.
Heuschkel, M; Krause, BJ; Kurth, J; Löser, A; Schwarzenböck, SM; Willenberg, HS, 2018
)
"The findings indicate that Lu-DOTATATE-PRRT is a safe and effective treatment method for patients with NEN."( Peptide receptor radionuclide therapy with 177Lu-DOTA-octreotate: dosimetry, nephrotoxicity, and the effect of hematological toxicity on survival.
Heuschkel, M; Krause, BJ; Kurth, J; Löser, A; Schwarzenböck, SM; Willenberg, HS, 2018
)
" We hypothesized that this unusual adverse event, never been reported so far, was the result of acute tumor irradiation after PRRT, leading to peritumoral inflammation and edema with obstruction of an accessory pancreatic duct."( Acute Pancreatitis Following Peptide Receptor Radionuclide Therapy: An Unusual Adverse Event.
Flamen, P; Hendlisz, A; Karfis, I; Machiels, G; Marin, G, 2018
)
"177Lu-DOTATATE therapy was feasible, highly effective, and safe in patients with advanced PanNETs heavily pretreated with chemotherapy."( 177Lu-DOTATATE Therapy of Advanced Pancreatic Neuroendocrine Tumors Heavily Pretreated with Chemotherapy: Analysis of Outcome, Safety, and Their Determinants.
Eriksson, B; Fröss-Baron, K; Garske-Roman, U; Granberg, D; Khan, T; Sandström, M; Sundin, A; Welin, S, 2021
)
"PRRT (peptide receptor radionuclide therapy) with Lu-DOTATATE for neuroendocrine tumor has some well-known adverse effects, concerning specially the bone marrow and kidneys."( Liver Steatosis Secondary to PRRT With 177Lu-DOTATATE: An Unknown Adverse Effect.
de Carvalho, JR; de Lima, BM; Gaspar, PR; Gonçalves, R; Pujatti, PB, 2020
)
" Because of persistent hepatic progression, a safe and successful administration of 4 cycles of a second series of PRRT under hemodialysis was administered."( Successful and Safe Treatment With 177Lu-DOTATATE (Lutathera) of Progressive Metastatic Pancreatic Neuroendocrine Tumor Under Hemodialysis.
Amel, B; Dierickx, LO; Fatima, M; Rosine, G; Séverine, B, 2020
)
"Findings of the study revealed that in the absence of the established treatment for the patients with RR-DTC and metastatic MTC, PRRT could be effective with few adverse events."( Efficacy and safety of peptide receptor radionuclide therapy in advanced radioiodine-refractory differentiated thyroid cancer and metastatic medullary thyroid cancer: a systematic review.
Emami, Z; Khamseh, ME; Maghsoomi, Z; Malboosbaf, R; Malek, M, 2021
)
" The vast majority of patients (96/100) was not restricted in treatment continuation by haematotoxicity; therefore, our selection criteria appeared appropriate for safe PRRT treatment."( Haematotoxicity during peptide receptor radionuclide therapy: Baseline parameters differences and effect on patient's therapy course.
de Vries-Huizing, DMV; de Wit-van der Veen, BJ; Geluk-Jonker, MM; Hendrikx, JJMA; Sinaasappel, M; Stokkel, MPM; Tesselaar, MET; Versleijen, MWJ; Walraven, I, 2021
)

Pharmacokinetics

ExcerptReference
" To this end, we developed pharmacokinetic digital phantoms corresponding to patients treated with (177)Lu-DOTATATE."( Pharmacokinetic digital phantoms for accuracy assessment of image-based dosimetry in (177)Lu-DOTATATE peptide receptor radionuclide therapy.
Brolin, G; Gleisner, KS; Gustafsson, J; Ljungberg, M, 2015
)
" An individual non-compartmental pharmacokinetic analysis was performed, and the mean pharmacokinetic parameters of each tissue were compared together and with reference data."( Clinical Pharmacokinetics of Radiopharmaceuticals from SPECT/CT Image Acquisition by Contouring in Patients with Gastroenteropancreatic Neuroendocrine Tumors: Lu-177 DOTATATE (Lutathera
Barakat, A; Deshayes, E; Khier, S; Kotzki, PO; Santoro, L; Vivien, M, 2023
)
"This study is a proof of concept that obtaining pharmacokinetic parameters with image-based blood concentration is possible."( Clinical Pharmacokinetics of Radiopharmaceuticals from SPECT/CT Image Acquisition by Contouring in Patients with Gastroenteropancreatic Neuroendocrine Tumors: Lu-177 DOTATATE (Lutathera
Barakat, A; Deshayes, E; Khier, S; Kotzki, PO; Santoro, L; Vivien, M, 2023
)

Compound-Compound Interactions

ExcerptReference
" We therefore started a randomised, controlled clinical trial to compare this combination with (177)Lu-octreotate as single agent with regard to anti-tumour effects and side effects."( Report on short-term side effects of treatments with 177Lu-octreotate in combination with capecitabine in seven patients with gastroenteropancreatic neuroendocrine tumours.
de Herder, WW; Kam, BL; Krenning, EP; Kwekkeboom, DJ; van Aken, MO; van Essen, M, 2008
)

Dosage Studied

ExcerptReference
" A weak but significant dose-response relationship for Gelofusine, but not for lysine, was found."( Molecular imaging of reduced renal uptake of radiolabelled [DOTA0,Tyr3]octreotate by the combination of lysine and Gelofusine in rats.
Bernard, BF; Boerman, OC; Breeman, WA; de Blois, E; de Jong, M; Forrer, F; Gotthardt, M; Hoppin, J; Krenning, EP; Rolleman, EJ, 2008
)
" A dose-response relationship was observed for proximal tubular damage, and a threshold dose value of 24 Gy (BED 37 Gy) was determined."( Nephrotoxicity profiles and threshold dose values for [177Lu]-DOTATATE in nude mice.
Bernhardt, P; Forssell-Aronsson, E; Konijnenberg, M; Mölne, J; Svensson, J, 2012
)
"Twenty-six patients received a mean full dosage (FD) of 25."( Treatment with the radiolabelled somatostatin analog Lu-DOTATATE for advanced pancreatic neuroendocrine tumors.
Ambrosetti, A; Bartolomei, M; Bodei, L; Garaboldi, L; Monti, M; Nanni, O; Paganelli, G; Sansovini, M; Sarnelli, A; Severi, S, 2013
)
"8 GBq, which can thus be considered the recommended dosage in eligible patients."( Treatment with the radiolabelled somatostatin analog Lu-DOTATATE for advanced pancreatic neuroendocrine tumors.
Ambrosetti, A; Bartolomei, M; Bodei, L; Garaboldi, L; Monti, M; Nanni, O; Paganelli, G; Sansovini, M; Sarnelli, A; Severi, S, 2013
)
"Twenty-five (58 %) patients were treated with a "standard" Lu-PRRT full dosage (FD) of 25."( 177 Lu-Dota-octreotate radionuclide therapy of advanced gastrointestinal neuroendocrine tumors: results from a phase II study.
Amadori, D; Ambrosetti, A; Donati, C; Ianniello, A; Matteucci, F; Monti, M; Paganelli, G; Sansovini, M; Scarpi, E; Severi, S, 2014
)
" In the present study, we investigated the use of low dosage re-treatment with (177)Lu-DOTATATE (Lu-PRRT) in patients with GEP-NENs who relapsed after treatment with (90)Y-DOTATOC (Y-PRRT)."( Feasibility and utility of re-treatment with (177)Lu-DOTATATE in GEP-NENs relapsed after treatment with (90)Y-DOTATOC.
Bodei, L; Caroli, P; D'Errico, V; Di Iorio, V; Ianniello, A; Ibrahim, T; Monti, M; Nicolini, S; Paganelli, G; Sansovini, M; Severi, S, 2015
)
"It was not possible to demonstrate a tumor dose-response relationship in SI-NET metastases with the applied dosimetry method, contrary to what was previously shown for pancreatic NETs."( 177Lu-DOTATATE Peptide Receptor Radionuclide Therapy: Dose Response in Small Intestinal Neuroendocrine Tumors.
Garske-Román, U; Ilan, E; Jahn, U; Lubberink, M; Sandström, M; Sundin, A, 2020
)
[information is derived through text-mining from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Research

Studies (347)

TimeframeStudies, This Drug (%)All Drugs %
pre-19900 (0.00)18.7374
1990's0 (0.00)18.2507
2000's38 (10.95)29.6817
2010's229 (65.99)24.3611
2020's80 (23.05)2.80
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Study Types

Publication TypeThis drug (%)All Drugs (%)
Trials41 (11.52%)5.53%
Reviews39 (10.96%)6.00%
Case Studies84 (23.60%)4.05%
Observational2 (0.56%)0.25%
Other190 (53.37%)84.16%
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Clinical Trials (68)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
A Phase 1b Trial of M3814 (Peposertib) in Combination With Lutetium 177 Dotatate for Well-Differentiated Somatostatin Receptor-Positive Gastroenteropancreatic Neuroendocrine Tumors (GEP-NETs)[NCT04750954]Phase 129 participants (Anticipated)Interventional2021-07-22Recruiting
A Phase I Trial of Triapine and Lutetium Lu 177 Dotatate in Combination for Well-Differentiated Somatostatin Receptor-Positive Gastroenteropancreatic Neuroendocrine Tumors (GEP-NETs)[NCT04234568]Phase 129 participants (Anticipated)Interventional2020-07-20Active, not recruiting
A Single Arm, Open-label, Multicenter Phase II Study of 177Lu-DOTATATE Radionuclide in Adults With Progressive or High-risk Meningioma[NCT03971461]Phase 232 participants (Anticipated)Interventional2019-05-15Recruiting
A Multicentre, Stratified, Open, Randomized, Comparator-controlled, Parallel-group Phase III Study Comparing Treatment With 177Lu-DOTA0-Tyr3-Octreotate to Octreotide LAR in Patients With Inoperable, Progressive, Somatostatin Receptor Positive Midgut Carci[NCT01578239]Phase 3231 participants (Actual)Interventional2012-09-06Completed
A Prospective Single-Arm, Multi-Centre, Study of the Efficacy and Safety of Lutetium-177 Octreotate (Lu-DOTATATE) Treatment With Individualized Dosimetry in Patients With 68Ga-DOTATATE Identified Somatostatin Receptor Positive Neuroendocrine Tumors[NCT02743741]195 participants (Actual)Interventional2016-07-15Active, not recruiting
Two Steps Italian Prospective obsErvationAL Study Assessing the Effectiveness and Outcomes Associated With LUtathera (177Lu) Oxodotreotide Treatment in Adult Subjects With Unresectable or Metastatic, Progressive, Well Differentiated (G1 and G2), Somatosta[NCT04727723]164 participants (Anticipated)Observational2021-03-09Active, not recruiting
A Phase Ib/II Study of Combination Avelumab With Peptide Receptor Radionuclide Therapy or Conventional Fractionated Radiotherapy in Patients With Metastatic Merkel Cell Carcinoma[NCT04261855]Phase 1/Phase 238 participants (Anticipated)Interventional2020-10-08Recruiting
Randomized, Open, Positive Control Phase III Clinical Trial of Lutetium (177Lu) Oxodotreotide Injection Combined With Standard-dose Long-acting Octreotide Versus High-dose Long-acting Octreotide in the Treatment of Somatostatin Receptor-positive Advanced [NCT05884255]Phase 3220 participants (Anticipated)Interventional2023-07-06Recruiting
Personalized Peptide Receptor Radionuclide Therapy of Neuroendocrine Tumors: A Phase 2 Study[NCT02754297]Phase 2300 participants (Anticipated)Interventional2016-04-12Recruiting
Preoperative PRRT Versus Surgical Cytoreduction Alone in Metastatic Pancreatic Neuroendocrine Tumors to the Liver: A Phase II Multi-institutional Trial[NCT05610826]Phase 1/Phase 252 participants (Anticipated)Interventional2023-03-07Recruiting
Trial of Lu-177 DOTATATE (Lutathera®) in Unlicensed Indications Including Bronchial and Thymic Neuroendocrine Tumour, Paraganglioma/Phaeochromocytoma, Medullary Thyroid Carcinoma, and Repeat Peptide Receptor Radionuclide Therapy[NCT06121271]Phase 2110 participants (Anticipated)Interventional2023-12-18Not yet recruiting
A Phase I Dose Escalation-Expansion Trial of Sunitinib Malate Plus Lutetium Lu 177 Dotatate (Lutathera) in Somatostatin Receptor Positive Pancreatic Neuroendocrine Tumors[NCT05687123]Phase 124 participants (Anticipated)Interventional2024-01-06Recruiting
Antitumor Efficacy of Peptide Receptor Radionuclide Therapy With 177Lutetium -Octreotate Randomized vs Sunitinib in Unresectable Progressive Well-differentiated Neuroendocrine Pancreatic Tumor: First Randomized Phase II.[NCT02230176]Phase 280 participants (Anticipated)Interventional2015-02-28Recruiting
Retrospective Analysis of Patients Re-treated With Lutetium-177 DOTATATE (Lutathera®)[NCT05816720]31 participants (Actual)Observational2021-09-01Completed
A Phase III Multi-center, Randomized, Open-label Study to Evaluate the Efficacy and Safety of Lutathera in Patients With Grade 2 and Grade 3 Advanced GEP-NET[NCT03972488]Phase 3222 participants (Actual)Interventional2020-01-22Active, not recruiting
Phase I Trial of Peptide Receptor Radiotherapy (PRRT) With 177Lu-DOTA-tyr3-Octreotate (177Lu-DOTATATE) in Children and Adolescents With Neuroendocrine Tumor or Pheochromocytoma/Paraganglioma[NCT03923257]Phase 1/Phase 20 participants (Actual)Interventional2020-08-04Withdrawn(stopped due to competing clinical trial opening)
A Study Comparing Treatment With Lutetium[177Lu] Oxodotreotide Injection to Octreotide LAR in Patients With Inoperable, Progressive, , Well Differentiated, Somatostatin Receptor Positive Gastroenteropancreatic Neuroendocrine Tumours[NCT05459844]Phase 3196 participants (Anticipated)Interventional2022-08-31Recruiting
A Phase II Randomized Control Trial of Triapine Plus Lutetium Lu 177 Dotatate Versus Lutetium Lu 177 Dotatate Alone for Well-Differentiated Somatostatin Receptor-Positive Neuroendocrine Tumors[NCT05724108]Phase 294 participants (Anticipated)Interventional2023-08-30Recruiting
Randomized Phase II Trial of Lutetium Lu 177 Dotatate Versus Everolimus in Somatostatin Receptor Positive Bronchial Neuroendocrine Tumors[NCT04665739]Phase 2108 participants (Anticipated)Interventional2023-02-03Recruiting
Phase I Trial With 177Lu-DOTA-TATE and Olaparib in Somatostatin Receptor Positive Tumours[NCT04375267]Phase 118 participants (Actual)Interventional2020-04-23Active, not recruiting
A Pilot Study of Pembrolizumab and Liver-Directed Therapy or Peptide Receptor Radionuclide Therapy for Patients With Well-Differentiated Neuroendocrine Tumors and Symptomatic and/or Progressive Metastases[NCT03457948]Phase 232 participants (Actual)Interventional2018-08-27Active, not recruiting
LUTATHERA Injection General Use Result Survey (Somatostatin Receptor-positive Neuroendocrine Tumor, CAAA601A11401)[NCT05844332]300 participants (Anticipated)Observational2021-12-17Recruiting
Peptide Receptor Radionuclide Therapy With 177Lu-Dotatate Associated With Metronomic Capecitabine In Patients Affected By Aggressive Gastro-Etero-Pancreatic Neuroendocrine Tumors[NCT02736500]Phase 1/Phase 237 participants (Actual)Interventional2015-09-02Active, not recruiting
A Phase Ib Dose Finding Study Assessing Safety and Activity of [177Lu]Lu-DOTA-TATE in Newly Diagnosed Extensive Stage Small Cell Lung Cancer (ES-SCLC) in Combination With Carboplatin, Etoposide and Tislelizumab in Induction and With Tislelizumab in Mainte[NCT05142696]Phase 139 participants (Anticipated)Interventional2022-07-13Recruiting
SEPTRALU, Spanish Series of Patients Treated With the Radionuclide Lutetium177[NCT04949282]5,000 participants (Anticipated)Observational2021-05-10Recruiting
NET RETREAT: A Phase II Study of 177 Lutetium-DOTATATE Retreatment vs. Everolimus in Metastatic/Unresectable Midgut NET[NCT05773274]Phase 2100 participants (Anticipated)Interventional2024-03-01Recruiting
A Phase I Clinical Study Evaluating the Safety of Peptide Receptor Radionuclide Therapy (PRRT) With 177Lu-DOTA0-Tyr3-Octreotate in Children With Refractory or Recurrent Neuroblastoma Expressing Somatostatin Receptors.[NCT03966651]Phase 118 participants (Anticipated)Interventional2023-04-17Recruiting
Clinical Study of the Use of Yttrium-90 (90Y) and/or Lutecium-177 (177Lu) DOTATATE (DOTA-0-Tyr3-Octreotate) in the Treatment of Disseminated and / or Symptomatic Tumors With Somatostatin Receptor Overexpression[NCT04029428]Phase 2150 participants (Anticipated)Interventional2004-11-02Recruiting
A Phase II Study to Evaluate the Effects of 177Lu-DOTATATE in Patients With Unresectable and Progressive Rare Metastatic Endocrine Carcinomas: Medullary Thyroid Cancer, Parathyroid Carcinoma, Pituitary Carcinoma, and Malignant Pheochromocytoma/Paraganglio[NCT04106843]Phase 20 participants (Actual)Interventional2019-06-13Withdrawn(stopped due to No Participants Registered)
Phase II Randomised Trial to Assess Progression of Carcinoid Heart Disease in Patients Treated With Lutathera Therapy Compared to Best Supportive Care.[NCT04039516]Phase 220 participants (Anticipated)Interventional2020-10-31Not yet recruiting
Biomarker Identification of Radionuclide Therapy-induced Radiation Responses[NCT05513469]20 participants (Anticipated)Interventional2023-01-01Recruiting
Carcinoid Tumors After Failure of Somatostatin Analogs: a Randomized Phase III of Octreotide Lutate Peptid Receptor Radionuclide Therapy (PRRT) Versus Interferon α-2b[NCT01860742]Phase 30 participants (Actual)Interventional2014-12-31Withdrawn
An Open Label Phase II, Registry Study of Lutetium-177 (DOTA0, TYR3) Octreotate (Lu-DOTA-TATE) Treatment in Patients With Somatostatin Receptor Positive Tumours[NCT02236910]Phase 266 participants (Actual)Interventional2014-07-31Active, not recruiting
A Multicenter Open-label Study to Evaluate Safety and Dosimetry of Lutathera in Adolescent Patients With Somatostatin Receptor Positive Gastroenteropancreatic Neuroendocrine (GEP-NET) Tumors, Pheochromocytoma and Paragangliomas (PPGL)[NCT04711135]Phase 211 participants (Actual)Interventional2022-08-31Active, not recruiting
A Prospective, Phase II Study of Lutetium Lu 177 Dotatate (LUTATHERA®) in Patients With Inoperable, Progressive Meningioma After External Beam Radiation Therapy[NCT04082520]Phase 241 participants (Anticipated)Interventional2020-04-08Recruiting
A Single Arm Study With Safety Run-in of Peptide Receptor Radionuclide Therapy (PRRT) in Combination With Immunotherapy for Patients With Merkel Cell Cancer (HCRN MCC20-443; iPRRT Study)[NCT05583708]Phase 218 participants (Anticipated)Interventional2023-08-03Recruiting
Expanded Access Protocol for Therapeutic Use of 177Lu-DOTA0-Tyr3-Octreotate in Patients With Inoperable, Somatostatin Receptor Positive, Neuroendocrine Tumors, Progressive Under Somatostatin Analogue Therapy[NCT02705313]0 participants Expanded AccessApproved for marketing
Dosimetry Based PRRT Versus Standard Dose PRRT With Lu-177-DOTATOC in NEN Patients- a Randomized Study; a Step Towards Tailored PRRT[NCT04917484]Phase 2100 participants (Anticipated)Interventional2020-02-01Recruiting
A Post Marketing Surveillance on Lutathera® (Lutetium (177Lu) Oxodotreotide, 177Lu-DOTA0-Tyr3-Octreotate) in Patients With Somatostatin Receptor Positive Gastroenteropancreatic Neuroendocrine Tumor (GEP-NET) in Korea[NCT04946305]50 participants (Anticipated)Observational2022-05-10Recruiting
An Open-label Phase II Study of Lutetium-177 [DOTA0, Tyr3] Octreotate (Lu-DOTA-TATE) Treatment in Patients With Somatostatin Receptor Positive Tumours[NCT01876771]Phase 2500 participants (Anticipated)Interventional2014-04-29Recruiting
The Epigenetic Modification of Somatostatin Receptor-2 to Improve Therapeutic Outcome With Lutathera in Patients With Metastatic Neuroendocrine Tumours.[NCT05178693]Phase 127 participants (Anticipated)Interventional2022-04-25Recruiting
"Imaging With 68Ga-DOTA-peptides and Peptide Receptor Radionuclide Therapy With 177Lu-DOTA-peptides of Gastroenteropancreatic Neuroendocrine Tumors: Interest of Intra-arterial Hepatic Infusion in Patients With Dominant Liver Metastases"[NCT04837885]Phase 220 participants (Anticipated)Interventional2021-09-24Recruiting
A Phase II Trial of 177Lutetium-DOTATATE in Children With Primary Refractory or Relapsed High-risk Neuroblastoma[NCT04903899]Phase 224 participants (Anticipated)Interventional2021-05-19Recruiting
Treatment of a Long-lasting Radiolabeled Somatostatin Analogue 177Lu-DOTA-EB-TATE in Patients With Advanced Metastatic Neuroendocrine Tumors[NCT03478358]Phase 160 participants (Anticipated)Interventional2017-04-30Recruiting
Phase I/II Study of Lutathera in Pediatric and Young Adult Patients With Recurrent and/or Progressive High-Grade Central Nervous System Tumors and Meningiomas That Express Somatostatin Type2A Receptors and Demonstrate Uptake on DOTATATE PET[NCT05278208]Phase 1/Phase 265 participants (Anticipated)Interventional2022-11-21Recruiting
A Phase II Pilot Study of (Lutetium (177Lu)-DOTATATE in Patients With Metastatic Breast Cancer[NCT04529044]Phase 210 participants (Anticipated)Interventional2022-09-01Not yet recruiting
A Phase Ib Dose Finding Study Assessing Safety and Activity of [177Lu]Lu-DOTA-TATE in Newly Diagnosed Glioblastoma in Combination With Radiotherapy With or Without Temozolomide and in Recurrent Glioblastoma as Single Agent[NCT05109728]Phase 160 participants (Anticipated)Interventional2022-05-10Recruiting
Pilot Phase 1 Study of Perioperative Peptide Receptor Radionuclide Therapy (PRRT) in Metastatic, WHO Grade 1 or 2, SSTR Positive, Gastroenteropancreatic Neuroendocrine Tumors Who Are Candidates for Cytoreductive Surgery[NCT04609592]Phase 110 participants (Anticipated)Interventional2021-03-17Recruiting
Phase Ib Study of Cabozantinib in Combination With Lu-177 DOTATATE Peptide Receptor Radionuclide Therapy (PRRT) in Patients With Progressive, Previously Treated Somatostatin Receptor 2 (SSTR2) Positive Neuroendocrine Tumors (NETs)[NCT05249114]Phase 190 participants (Anticipated)Interventional2022-12-28Recruiting
A Phase II Study of Lutetium Lu 177 Dotatate in Metastatic Prostate Cancer With Neuroendocrine Differentiation[NCT05691465]Phase 230 participants (Anticipated)Interventional2024-01-19Recruiting
A Multicenter Phase II-Study Evaluating Efficacy and Safety of 177Lu-DOTA-TATE Based on Kidney-Dosimetry in Patients With Disseminated Neuroendocrine Tumors[NCT01456078]Phase 260 participants (Actual)Interventional2011-10-31Completed
Phase I/II Trial of Anti-PD-1 Checkpoint Inhibitor Nivolumab and 177Lu-DOTA0-Tyr3-Octreotate for Patients With Extensive-Stage Small Cell Lung Cancer[NCT03325816]Phase 1/Phase 29 participants (Actual)Interventional2017-11-20Completed
A Prospective Phase II Single-Arm Trial on Neoadjuvant Peptide Receptor Radionuclide Therapy With 177Lu-DOTATATE Followed by Surgery for Resectable Pancreatic Neuroendocrine Tumors[NCT04385992]Phase 231 participants (Actual)Interventional2020-03-09Completed
177Lutetium-DOTA-Octreotate Therapy in Somatostatin Receptor-Expressing Neuroendocrine Neoplasms[NCT01237457]Phase 2143 participants (Actual)Interventional2010-10-27Completed
A Pilot Study Investigating Intrahepatic Arterial And Intravenous Infusion Of The Radiolabeled Somatostatin Agonist 177Lu-DOTATATE In Patients With Liver-Dominant Metastatic Gastroenteropancreatic (GEP), Bronchial or Unknown Primary Well Differentiated Ne[NCT04544098]Early Phase 110 participants (Anticipated)Interventional2020-09-02Recruiting
Dosimetry-Guided 177Lu-DOTATATE Treatment Planning Using 64Cu-DOTATATE as a Surrogate[NCT06122610]Phase 110 participants (Anticipated)Interventional2024-02-29Not yet recruiting
An International Multi-centre, Stratified, Open, Randomized, Comparator-controlled, Parallel-group Phase II Study Comparing Adjuvant Treatment With 177Lu-DOTATATE (Lutathera®) to Best Supportive Care in Patients After Resection of Neuroendocrine Liver Met[NCT05987176]Phase 290 participants (Anticipated)Interventional2023-11-01Not yet recruiting
International, Non-interventional, Post-Authorization Long-Term Safety Study of Lutathera, in Patients With Unresectable or Metastatic, Well-Differentiated, Somatostatin Receptor Positive, Gastroenteropancreatic Neuroendocrine Tumours[NCT03691064]1,014 participants (Actual)Observational2018-11-28Active, not recruiting
The LuMEn Study: 177Lu-octreotate Treatment Outcome Prediction Using Multimodality Imaging in Refractory Neuroendocrine Tumours.[NCT01842165]Phase 337 participants (Actual)Interventional2013-05-31Completed
A Prospective Randomized Phase II Study Assess the Schema of Retreatment With Lutathera® ([177LU]LU-DOTA-TATE) in Patients With New Progression of Intestinal Well-differenciated Neuroendocrine Tumor[NCT04954820]Phase 2146 participants (Anticipated)Interventional2021-10-18Recruiting
Surgical Debulking Prior to Peptide Receptor Radionuclide Therapy (PRRT) in Patients With Well Differentiated Gastroenteropancreatic Neuroendocrine Tumors[NCT06016855]Phase 46 participants (Anticipated)Interventional2023-09-01Not yet recruiting
Phase II Study to Evaluate the Efficacy and Safety of 177Lu-Dotatate in the First-line Treatment of Inoperable Patients With Locally Advanced or Metastatic, Somatostatin Receptor-positive G2 or G3 Gastroenteropancreatic Neuroendocrine Tumors[NCT05894486]Phase 240 participants (Anticipated)Interventional2023-06-05Not yet recruiting
Peptide Receptor Radionuclide Therapy (PRRT) With Radiolabelled Somatostatin Analogue 177Lu-DOTATATE in Advanced Gastro-entero Pancreatic Neuroendocrine Tumors, 18F-2-fluoro-2-deoxy-D-glucose (FDG)-PET Negative Patients: a Prospective Phase II Randomized [NCT02489604]Phase 270 participants (Actual)Interventional2013-12-31Active, not recruiting
Phase II Randomized, Prospective Trial of Lutetium Lu 177 Dotatate PRRT Versus Capecitabine and Temozolomide in Well-Differentiated Pancreatic Neuroendocrine Tumors[NCT05247905]Phase 2198 participants (Anticipated)Interventional2022-03-16Recruiting
Study to Evaluate the Efficacy and Safety of 177Lu-Dotatate PRRT in Metastatic GEP-NEN Patients[NCT03422029]Phase 220 participants (Anticipated)Interventional2018-01-31Recruiting
Intra-arterial Lutetium-177-dotatate for Treatment of Patients With Neuro-endocrine Tumor Liver Metastases[NCT03590119]Phase 2/Phase 326 participants (Actual)Interventional2018-08-01Completed
A Phase II Single Arm Trial Evaluating the Preliminary Efficacy of the Combination of 177Lu-DOTATATE and Nivolumab in Grade 3 Well-differentiated Neuroendocrine Tumours (NET) or Poorly Differentiated Neuroendocrine Carcinomas (NEC)[NCT04525638]Phase 230 participants (Anticipated)Interventional2020-06-29Recruiting
A Phase 1/2 Trial Using AZEDRA and LUTATHERA in a Dosimetrically-determined Optimal Combination for Therapy of Selected Patients With Midgut Neuroendocrine Tumors[NCT04614766]Phase 1/Phase 250 participants (Anticipated)Interventional2022-09-30Recruiting
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

TrialOutcome
NCT01578239 (11) [back to overview]Duration of Response (DoR)
NCT01578239 (11) [back to overview]Objective Response Rate (ORR)
NCT01578239 (11) [back to overview]Overall Survival (OS)
NCT01578239 (11) [back to overview]Progression Free Survival (PFS)
NCT01578239 (11) [back to overview]Time to Tumour Progression (TTP)
NCT01578239 (11) [back to overview]Change From Baseline in the EORTC QLQ-C30 Questionnaire
NCT01578239 (11) [back to overview]Change From Baseline in the EORTC QLQ-C30 Questionnaire
NCT01578239 (11) [back to overview]Change From Baseline in the EORTC Quality of Life Questionnaire - Neuroendocrine Carcinoid Module (EORTC QLQ-GINET21)
NCT01578239 (11) [back to overview]Change From Baseline in the EORTC Quality of Life Questionnaire - Neuroendocrine Carcinoid Module (EORTC QLQ-GINET21)
NCT01578239 (11) [back to overview]Number of Participants With Adverse Events
NCT01578239 (11) [back to overview]Rate of Overall Survival (OS)
NCT03325816 (2) [back to overview]Number of Participants With Treatment Related Adverse Events
NCT03325816 (2) [back to overview]Phase I - Recommended Phase II Dose (RP2D) of 177Lu-DOTA0-Tyr3-Octreotate

Duration of Response (DoR)

The Duration of Response (DoR) was defined as the time from initially meeting the criteria for response (CR or PR) until the time of progression by RECIST 1.1. (NCT01578239)
Timeframe: From date of randomization until date of progression or date of death from any cause, whichever comes first until Primary Analysis cutoff date reached on 24July2015, assessed up to approximately 34 months

InterventionMonths (Median)
177Lu-DOTA0-Tyr3-OctreotateNA
Octreotide LAR1.9

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Objective Response Rate (ORR)

Objective Response Rate (ORR) was calculated as the proportion of patients with tumour size reduction (sum of partial responses (PR) and complete responses (CR)) according to RECIST 1.1. (NCT01578239)
Timeframe: From date of randomization until date of progression or date of death from any cause, whichever comes first until Primary Analysis cutoff date reached on 24July2015, assessed up to approximately 34 months

InterventionPercentage of Participants (Number)
177Lu-DOTA0-Tyr3-Octreotate14.7
Octreotide LAR4.0

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Overall Survival (OS)

Overall Survival (OS) was defined as the time from the date of randomization to the date of death due to any cause or the date of last contact (censored observation) prior to the date of the data cut-off, and during the entire study period (i.e. the treatment period plus follow-up). (NCT01578239)
Timeframe: From date of randomization until date of death from any cause up to final safety cut-off date reached on 18Jan2021, assessed up to approximately 100 months

InterventionMonths (Median)
177Lu-DOTA0-Tyr3-Octreotate48.0
Octreotide LAR36.3

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Progression Free Survival (PFS)

Progression Free Survival (PFS) was defined as the time from randomization to documented centrally assessed disease progression, as evaluated by the Independent Review Committee (IRC), or death due to any cause. If a participant had no centrally assessed progression and had not died at the time of the primary endpoint analysis, the participant was regarded as censored in the context of a time to event analysis at the date of last evaluable tumor assessment. Disease progression was determined by objective tumor response status using Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1). (NCT01578239)
Timeframe: From date of randomization until date of radiographic progression or date of death from any cause, whichever comes first until Primary Analysis cutoff date reached on 24July2015, assessed up to approximately 34 months

Interventionmonths (Median)
177Lu-DOTA0-Tyr3-OctreotateNA
Octreotide LAR8.5

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Time to Tumour Progression (TTP)

Time to Tumour Progression (TTP) was defined as the time from randomization to progression centrally assessed. It included patients who dropped out due to toxicity, but omitted patients who died without measured progression (censored to last follow-up date or death date). (NCT01578239)
Timeframe: From date of randomization until date of progression or date of death from any cause, whichever comes first until Primary Analysis cutoff date reached on 24July2015, assessed up to approximately 34 months

InterventionMonths (Median)
177Lu-DOTA0-Tyr3-OctreotateNA
Octreotide LAR8.7

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Change From Baseline in the EORTC QLQ-C30 Questionnaire

"The Quality of Life Questionnaire C30 (QLQ-C30) was developed by the European Organization for Research and Treatment of Cancer (EORTC) to assess quality of life in cancer patients. It includes five function domains (physical, emotional, social, role, cognitive), eight symptoms (fatigue, pain, nausea/vomiting, constipation, diarrhea, insomnia, dyspnea, and appetite loss), as well as global health/quality-of-life and financial impact. Subjects respond on a four-point scale from not at all to very much for most items. Raw scores are linearly transformed so each score ranged a 0-100, where higher scores indicate worse symptoms (e.g., more severe/worsened) and lower scores indicate less symptoms (e.g., less severe/improvement)." (NCT01578239)
Timeframe: Inclusion (Baseline) (BL), Week 72, Week 120

InterventionScores on a scale (Mean)
Physical functioning: chg from BL @ wk 72 (n=33,11)Role functioning: chg from BL @ wk 72 (n=33,11)Emotional functioning: chg from BL @ wk 72 (n=33,11)Cognitive functioning: chg from BL @ wk 72 (n=33,11)Social functioning: chg from BL @ wk 72 (n=33,11)Global Health Status/QoL: chg from BL @ wk 72 (n=33,11)Fatigue: chg from BL @ wk 72 (n=33,11)Nausea & Vomiting: chg from BL @ wk 72 (n=33,11)Pain: chg from BL @ wk 72 (n=33,11)Dyspnoea: chg from BL @ wk 72 (n=33,11)Insomnia: chg from BL @ wk 72 (n=33,11)Appetite loss: chg from BL @ wk 72 (n=33,11)Constipation: chg from BL @ wk 72 (n=33,11)Diarrhoea: chg from BL @ wk 72 (n=33,11)Financial difficulties: chg from BL @ wk 72 (n=33,11)
Octreotide LAR-4.242-3.0306.0611.515-7.5761.515-2.020-4.545-3.0303.0306.0619.0910.000-3.0306.061

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Change From Baseline in the EORTC QLQ-C30 Questionnaire

"The Quality of Life Questionnaire C30 (QLQ-C30) was developed by the European Organization for Research and Treatment of Cancer (EORTC) to assess quality of life in cancer patients. It includes five function domains (physical, emotional, social, role, cognitive), eight symptoms (fatigue, pain, nausea/vomiting, constipation, diarrhea, insomnia, dyspnea, and appetite loss), as well as global health/quality-of-life and financial impact. Subjects respond on a four-point scale from not at all to very much for most items. Raw scores are linearly transformed so each score ranged a 0-100, where higher scores indicate worse symptoms (e.g., more severe/worsened) and lower scores indicate less symptoms (e.g., less severe/improvement)." (NCT01578239)
Timeframe: Inclusion (Baseline) (BL), Week 72, Week 120

InterventionScores on a scale (Mean)
Physical functioning: chg from BL @ wk 72 (n=33,11)Physical functioning: chg from BL @ wk 120 (n=2,0)Role functioning: chg from BL @ wk 72 (n=33,11)Role functioning: chg from BL @ wk 120 (n=2,0)Emotional functioning: chg from BL @ wk 72 (n=33,11)Emotional functioning: chg from BL @ wk 120 (n=2,0)Cognitive functioning: chg from BL @ wk 72 (n=33,11)Cognitive functioning: chg from BL @ wk 120 (n=2,0)Social functioning: chg from BL @ wk 72 (n=33,11)Social functioning: chg from BL @ wk 120 (n=2,0)Global Health Status/QoL: chg from BL @ wk 72 (n=33,11)Global Health Status/QoL: chg from BL @ wk 120 (n=2,0)Fatigue: chg from BL @ wk 72 (n=33,11)Fatigue: chg from BL @ wk 120 (n=2,0)Nausea & Vomiting: chg from BL @ wk 72 (n=33,11)Nausea & Vomiting: chg from BL @ wk 120 (n=2,0)Pain: chg from BL @ wk 72 (n=33,11)Pain: chg from BL @ wk 120 (n=2,0)Dyspnoea: chg from BL @ wk 72 (n=33,11)Dyspnoea: chg from BL @ wk 120 (n=2,0)Insomnia: chg from BL @ wk 72 (n=33,11)Insomnia: chg from BL @ wk 120 (n=2,0)Appetite loss: chg from BL @ wk 72 (n=33,11)Appetite loss: chg from BL @ wk 120 (n=2,0)Constipation: chg from BL @ wk 72 (n=33,11)Constipation: chg from BL @ wk 120 (n=2,0)Diarrhoea: chg from BL @ wk 72 (n=33,11)Diarrhoea: chg from BL @ wk 120 (n=2,0)Financial difficulties: chg from BL @ wk 72 (n=33,11)Financial difficulties: chg from BL @ wk 120 (n=2,0)
177Lu-DOTA0-Tyr3-Octreotate3.232-3.3335.0518.3337.74412.5005.55616.6678.5868.3335.556-16.667-7.23911.111-4.5450.000-8.5860.000-3.0300.0000.00033.333-8.0810.0000.0000.000-12.121-16.667-7.071-16.667

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Change From Baseline in the EORTC Quality of Life Questionnaire - Neuroendocrine Carcinoid Module (EORTC QLQ-GINET21)

The Quality of Life GI Neuroendocrine Tumor survey (QLQ GINET21) contains a total of 21 items: four single-item assessments relating to muscle and/or bone pain (MBP), body image (BI), information (INF) and sexual functioning (SX), together with 17 items organized into five proposed scales: endocrine symptoms (ED; three items), GI symptoms (GI; five items), treatment-related symptoms (TR; three items), social functioning (SF) and disease-related worries (DRW; three items). The response format of the questionnaire is a four-point Likert scale. Responses are linearly transformed to a 0-100 scale using EORTC guidelines, with higher scores reflecting more severe symptoms. (NCT01578239)
Timeframe: Inclusion (Baseline) (BL), Week 72, Week 120

InterventionScores on a scale (Mean)
Endocrine scale: chg from BL @ wk 72 (n=33,11)Endocrine scale: chg from BL @ wk 120 (n=2,0)G.I. scale: chg from BL @ wk 72 (n=33,11)G.I. scale: chg from BL @ wk 120 (n=2,0)Treatment scale: chg from BL @ wk 72 (n=21,5)Treatment scale: chg from BL @ wk 120 (n=1,0)Social function scale: chg from BL @ wk 72 (n=33,11)Social function scale: chg from BL @ wk 120 (n=2,0)Diseases rel. worries scale: chg from BL @ wk 72 (n=33,11)Diseases rel. worries scale: chg from BL @ wk 120 (n=2,0)Muscle/Bone pain symptom: chg from BL @ wk 72 (n=33,10)Muscle/Bone pain symptom: chg from BL @ wk 120 (n=2,0)Sexual function: chg from BL @ wk 72 (n=21,7)Sexual function: chg from BL @ wk 120 (n=2,0)Information/Communication: chg from BL @ wk 72 (n=33,11)Information/Communication: chg from BL @ wk 120 (n=2,0)Body image: chg from BL @ wk 72 (n=33,11)Body image: chg from BL @ wk 120 (n=2,0)
177Lu-DOTA0-Tyr3-Octreotate-8.7540.000-2.727-13.333-8.995-16.667-7.57611.111-6.06133.333-5.051-16.6676.34950.000-4.0400.000-4.04016.667

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Change From Baseline in the EORTC Quality of Life Questionnaire - Neuroendocrine Carcinoid Module (EORTC QLQ-GINET21)

The Quality of Life GI Neuroendocrine Tumor survey (QLQ GINET21) contains a total of 21 items: four single-item assessments relating to muscle and/or bone pain (MBP), body image (BI), information (INF) and sexual functioning (SX), together with 17 items organized into five proposed scales: endocrine symptoms (ED; three items), GI symptoms (GI; five items), treatment-related symptoms (TR; three items), social functioning (SF) and disease-related worries (DRW; three items). The response format of the questionnaire is a four-point Likert scale. Responses are linearly transformed to a 0-100 scale using EORTC guidelines, with higher scores reflecting more severe symptoms. (NCT01578239)
Timeframe: Inclusion (Baseline) (BL), Week 72, Week 120

InterventionScores on a scale (Mean)
Endocrine scale: chg from BL @ wk 72 (n=33,11)G.I. scale: chg from BL @ wk 72 (n=33,11)Treatment scale: chg from BL @ wk 72 (n=21,5)Social function scale: chg from BL @ wk 72 (n=33,11)Diseases rel. worries scale: chg from BL @ wk 72 (n=33,11)Muscle/Bone pain symptom: chg from BL @ wk 72 (n=33,10)Sexual function: chg from BL @ wk 72 (n=21,7)Information/Communication: chg from BL @ wk 72 (n=33,11)Body image: chg from BL @ wk 72 (n=33,11)
Octreotide LAR-11.1112.4240.000-7.5761.010-16.66714.286-12.121-3.030

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Number of Participants With Adverse Events

The distribution of adverse events was done via the analysis of frequencies for Adverse Event (AEs), Serious Adverse Event (SAEs) and Deaths, through the monitoring of relevant clinical and laboratory safety parameters. (NCT01578239)
Timeframe: From informed consent signature through study completion reached at final safety cutoff date on 18July2021, assessed up to approximately 101 Months

,
InterventionParticipants (Count of Participants)
Adverse Events (AEs)Serious Adverse Events (SAEs)Deaths during treatment periodDeaths during follow-up period
177Lu-DOTA0-Tyr3-Octreotate10540466
Octreotide LAR9031563

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Rate of Overall Survival (OS)

Survival estimates were collected every 12 Months up to 60 Months to compare OS between the two treatment groups. (NCT01578239)
Timeframe: 12 months, 24 months, 36 months, 48 months, 60 months

,
InterventionPercentage of Survival Estimates (Number)
12 months24 months36 months48 months60 months
177Lu-DOTA0-Tyr3-Octreotate91.076.061.449.537.1
Octreotide LAR79.762.750.141.835.4

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