5-aminolevulinic-acid-hexyl-ester and Carcinoma-in-Situ

Topics: Aminolevulinic Acid; Carcinoma in Situ; Cystoscopy; Humans; Neoplasm Invasiveness; Photosensitizing Agents; Randomized Controlled Trials as Topic; Sensitivity and Specificity; Urinary Bladder Neoplasms

Studies on hexaminolevulinate (HAL) cystoscopy report improved detection of bladder tumours. However, recent meta-analyses report conflicting effects on recurrence.. To assess available clinical data for blue light (BL) HAL cystoscopy on the detection of Ta/T1 and carcinoma in situ (CIS) tumours, and on tumour recurrence.. This meta-analysis reviewed raw data from prospective studies on 1345 patients with known or suspected non-muscle-invasive bladder cancer (NMIBC).. A single application of HAL cystoscopy was used as an adjunct to white light (WL) cystoscopy.. We studied the detection of NMIBC (intention to treat [ITT]: n=831; six studies) and recurrence (per protocol: n=634; three studies) up to 1 yr. DerSimonian and Laird's random-effects model was used to obtain pooled relative risks (RRs) and associated 95% confidence intervals (CIs) for outcomes for detection.. BL cystoscopy detected significantly more Ta tumours (14.7%; p<0.001; odds ratio [OR]: 4.898; 95% CI, 1.937-12.390) and CIS lesions (40.8%; p<0.001; OR: 12.372; 95% CI, 6.343-24.133) than WL. There were 24.9% patients with at least one additional Ta/T1 tumour seen with BL (p<0.001), significant also in patients with primary (20.7%; p<0.001) and recurrent cancer (27.7%; p<0.001), and in patients at high risk (27.0%; p<0.001) and intermediate risk (35.7%; p=0.004). In 26.7% of patients, CIS was detected only by BL (p<0.001) and was also significant in patients with primary (28.0%; p<0.001) and recurrent cancer (25.0%; p<0.001). Recurrence rates up to 12 mo were significantly lower overall with BL, 34.5% versus 45.4% (p=0.006; RR: 0.761 [0.627-0.924]), and lower in patients with T1 or CIS (p=0.052; RR: 0.696 [0.482-1.003]), Ta (p=0.040; RR: 0.804 [0.653-0.991]), and in high-risk (p=0.050) and low-risk (p=0.029) subgroups. Some subgroups had too few patients to allow statistically meaningful analysis. Heterogeneity was minimised by the statistical analysis method used.. This meta-analysis confirms that HAL BL cystoscopy significantly improves the detection of bladder tumours leading to a reduction of recurrence at 9-12 mo. The benefit is independent of the level of risk and is evident in patients with Ta, T1, CIS, primary, and recurrent cancer.

Topics: Aminolevulinic Acid; Carcinoma in Situ; Cystoscopy; Humans; Kaplan-Meier Estimate; Neoplasm Invasiveness; Neoplasm Recurrence, Local; Neoplasm Staging; Predictive Value of Tests; Risk Factors; Time Factors; Treatment Outcome; Urinary Bladder; Urinary Bladder Neoplasms

Bladder cancer is the most common tumor of the urinary tract, with a worldwide incidence of 8.6 x 100000 in men and 2.6 x 100000 in women (1). The majority of patients (75-85%) present as non-muscle invasive bladder cancer (NMIBC); within this category the most represented stage is Ta (70%), followed by T1 (20%) and, less frequently, carcinoma in situ (CIS) (10%) (2). The diagnosis of NMIBC and, more generally, of bladder cancer, depends on urine cytology and endoscopic examination with histological evaluation of the resected tissue. Clearly, an optimal cystoscopy with accurate transurethral resection (TUR) is of great importance in order to improve the detection rate and to reduce the probability of recurrence and progression. Today the cystoscopy is routinely performed with the white light technique (WLC), the same of about 80 years ago (3). Several studies have demonstrated that an initial TUR with WLC can miss small papillary lesions and, particularly, flat lesions such as CIS. Moreover, recurrence rates of non-muscle invasive bladder cancer (NMIBC) are directly related to the possibility of achieving a complete resection: residual cancer is present in a large percentage of re-TUR, showing a not so good performance of resection with this method. For these reasons new methodologies have been investigated in order to improve the sensitivity and specificity of WLC, such as photodynamic diagnosis (PDD), narrow band imaging (NBI), optical coherence tomography (OCT) and CT virtual cystoscopy. Some of them have been well established and supported by consistent literature while others are still to be viewed as experimental. The purpose of this review is to investigate the state of the art of these new techniques.

Topics: Aminolevulinic Acid; Carcinoma in Situ; Carcinoma, Transitional Cell; Cystoscopy; False Negative Reactions; Female; Forecasting; Humans; Light; Male; Multimodal Imaging; Neoplasm Recurrence, Local; Photosensitizing Agents; Protoporphyrins; Sensitivity and Specificity; Tomography, Optical Coherence; Tomography, X-Ray Computed; Urinary Bladder Neoplasms

The question whether conventional cystoscopy should always be performed together with fluorescent diagnostic procedures remains to be answered. The current article presents the current literature dealing with this topic. Particularly for relevant carcinoma in situ lesions of the bladder there is no obvious advantage for photodynamic diagnostics compared to conventional cystoscopy with consistent use of urine cytology.

Topics: Aminolevulinic Acid; Carcinoma in Situ; Carcinoma, Transitional Cell; Cystoscopy; Fluorescence; Humans; Neoplasm Grading; Photosensitizing Agents; Predictive Value of Tests; Urinary Bladder Neoplasms

In flat bladder cancer and carcinoma in situ, and in multifocal papillary cancer, some smaller lesions may be overlooked at cystoscopy. For 10 years fluorescence cystoscopy has been promoted to solve these problems without wider acceptance. New fluorophobes now promise better clinical applicability.. In prospective multicenter studies fluorescence cystoscopy shows significant improvement in the detection of flat bladder cancer and carcinoma in situ. It also permits more reliable identification of all neoplastic lesions with multifocal tumors, hence more precise removal and as a consequence lower recurrence rates.. New agents bring a significant benefit. Hexyl-aminolevulinate offers more rapid urothelial accumulation, better fluorescence contrast and less photobleaching than previously used fluorophobes. It is simple to use in everyday practice and has a favorable toxicity profile.

Topics: Aminolevulinic Acid; Anthracenes; Carcinoma in Situ; Cystoscopy; Fluorescence; Fluorescent Dyes; Humans; Perylene; Practice Guidelines as Topic; Predictive Value of Tests; Sensitivity and Specificity; Urinary Bladder Neoplasms

Bladder cancer is a frequent disease and represents the second most common genitourinary neoplasm. Although many aspects of the management of not-muscle-infiltrating bladder cancer are now well established, significant challenges remain, which influence patient outcome. Early detection and treatment of recurrent disease is required to optimize bladder preservation, reduce patient morbidity and increase quality of life and survival. Fluorescence cystoscopy, often referred to as "photodynamic diagnosis" (PDD) with intravesical application of photosensitizing agents has been developed in order to enhance the early detection of bladder cancer. Since March 2005 the hexyl-ALA ester (Hexvix) has been approved for the diagnosis of bladder cancer in 27 EU/EEA countries through the European Mutual Recognition Procedure. There is growing evidence that PDD enhances the detection of bladder cancer, particularly of high-grade flat lesions. Furthermore, transurethral resection of bladder tumor under fluorescence guidance has been shown to reduce the risk of recurrent tumors. Nevertheless, a resulting relatively decreased number of recurrences have still to be verified in prospective randomized trials.

Topics: Aminolevulinic Acid; Biopsy; Carcinoma in Situ; Carcinoma, Transitional Cell; Cystoscopy; Fluorescence; Humans; Photosensitizing Agents; Predictive Value of Tests; Sensitivity and Specificity; Urinary Bladder; Urinary Bladder Neoplasms

Urology is a preferential domain of endoscopy and as such an important research field for photodynamic procedures. An important milestone in the long-lasting and successful history of "photodynamics" in urology is the European approval of hexaminolevulinate (HAL, Hexvix) for fluorescence cystoscopy. All clinical studies carried out so far have demonstrated a significant increase in sensitivity of fluorescence versus standard cystoscopy for the detection of bladder cancer, especially concerning carcinoma in situ. The majority of the randomised, two-armed studies additionally show significantly reduced rates of residual tumour and recurrences. Tumor-selective fluorescence can also be observed in the kidney and prostate. Intraoperative fluorescence detection might thus simplify the achievement of high rates of R0 resections. Apart from the diagnostic potential of "photodynamics", also some possible therapeutic indications will be mentioned, including photodynamic therapy of bladder cancer and prostate cancer. Whereas initial clinical experience has been obtained for photodynamic therapy of bladder cancer, clinical studies for other indications are currently being designed. By providing an overview over methods and procedures as well as hitherto the available clinical results, we hope to provide reader with a basis for obtaining his/her own judgement.

Topics: Aminolevulinic Acid; Carcinoma in Situ; Clinical Trials, Phase I as Topic; Clinical Trials, Phase II as Topic; Cystoscopy; Dermatitis, Phototoxic; Fluorescence; Follow-Up Studies; Humans; Male; Multicenter Studies as Topic; Neoplasm Recurrence, Local; Photochemotherapy; Photosensitizing Agents; Pilot Projects; Prostatic Neoplasms; Randomized Controlled Trials as Topic; Sensitivity and Specificity; Time Factors; Urinary Bladder Neoplasms

High-risk human papilloma virus (HPV)-associated cervical cancer is the fourth most common cancer in women worldwide. Current treatments of high-grade squamous intraepithelial lesion (HSIL) of the cervix are based on invasive surgical interventions, compromising cervical competence and functionality. APRICITY is a multicentre, prospective, double-blind, randomised controlled phase 3 study further evaluating the efficacy and safety of Cevira, an integrated drug-delivery and light-delivery device for hexaminolevulinate photodynamic therapy, which shows promise as a novel, non-invasive outpatient therapy for women with HSIL.. Patients with biopsy-confirmed HSIL histology are invited to participate in the study planned to be conducted at 47 sites in China and 25 sites in Ukraine, Russia and the European Union. The aim is to include at least 384 patients, which will be randomised to either Cevira or placebo group (2:1). All patients will be assessed 3 months after first treatment and a second treatment will be administered in patients who are HPV positive or have at least low-grade squamous intraepithelial lesion. Primary endpoint is the proportion of the responders 6 months after first treatment. Secondary efficacy and safety endpoints will be assessed at 6 months, and data for secondary performance endpoints of the Cevira device will be collected at 3 months and 6 months, in case second treatment was administered. All patients in the Cevira group will be enrolled in an open, long-term extension study for 6 months to collect additional efficacy and safety data (study extension endpoints).. The study was approved by the ethics committee of the Peking Union Medical College Hospital and Hannover Medical University, Germany. Findings will be disseminated through peer review publications and conference presentations.. NCT04484415; clinicaltrials.gov.

Topics: Aminolevulinic Acid; Carcinoma in Situ; Clinical Trials, Phase III as Topic; Female; Humans; Multicenter Studies as Topic; Papillomavirus Infections; Photochemotherapy; Prospective Studies; Randomized Controlled Trials as Topic; Squamous Intraepithelial Lesions; Uterine Cervical Neoplasms

To examine whether photodynamic diagnosis (PDD) in addition to flexible cystoscopy in the outpatient clinic can reduce risk of tumor recurrence in patients with previous nonmuscle invasive bladder cancer. PDD is an optical technique that enhances the visibility of pathologic tissue and helps guidance tumor resection.. From February 2016 to December 2017, 699 patients from 3 urologic departments in Denmark were enrolled in a randomized controlled trial. Four months after transurethral resection of bladder tumor patients were randomized 1:1 to either an intervention group (hexaminolevulinate was instilled in the bladder before flexible cystoscopy with PDD video cystoscope) or a control group (white light flexible cystoscope), only. Primary endpoint was tumor recurrence within 8 months from the randomization. Secondary outcomes were numbers of procedures in general anesthesia, time to the first recurrence, differences in tumor size, risk of tumor progression, and identification of carcinoma in situ.. A total of 351 patients were allocated to the intervention group (flexible PDD), and 348 to the control group (flexible white light). Throughout the following 8 months after randomization, only 117 patients in the intervention group had at least 1 tumor recurrence compared to 143 patients in the control group (P = .049). Odds ratio of 0.67 (P = .02, 95% CI: 0.48-0.95) correlates with a tumor reduction of 33% in favor of the intervention group.. Use of PDD in a routine surveillance cystoscopy first time after transurethral resection of bladder tumor for nonmuscle invasive bladder cancer reduces subsequent risk of tumor recurrence compared to WL cystoscopy alone.

Topics: Aged; Aminolevulinic Acid; Carcinoma in Situ; Cystoscopy; Female; Humans; Image Enhancement; Male; Neoplasm Recurrence, Local; Neoplasm Staging; Outcome Assessment, Health Care; Patient Selection; Photosensitizing Agents; Reproducibility of Results; Urinary Bladder; Urinary Bladder Neoplasms

To determine the potential for hexylaminolevulinate (HAL) photodynamic diagnosis (PDD) to improve the management of multifocal recurrent nonmuscle-invasive bladder cancer (NMIBC).. Patients with a history of NMIBC and with at least two suspected papillary recurrences were enrolled in this prospective study between April 2005 and October 2006. The photosensitizer was hexylaminolevulinate (HAL) (PhotoCure, Norway), and the Storz D-light system was used to detect fluorescence. The bladder was mapped initially under white light and then using HAL-photodynamic diagnosis (PDD). The number and types of additional lesions detected by HAL-PDD over white light cystoscopy were measured.. Eighteen patients (11 men), median age 74 years (range 35-84 yrs), underwent HAL-PDD. The median HAL instillation time was 109 minutes (range 60-250 min). Recurrent bladder cancer was confirmed histologically in 14/18 (78%) patients. Additional pathology was detected in 8/14 (57%) patients with confirmed recurrence and confirmed histologically in 6 of these. Additional pathology was papillary in 5/6 (83%) patients, and flat pathology was found in all six patients with additional foci. Carcinoma in situ (CIS) was detected in 4/6 (67%) patients with additional foci, three of whom were subsequently treated with intravesical bacille Calmette-Guérin (BCG). The sensitivity of HAL-PDD for the detection of tumor was 97.8%, compared with 69.6% for white light cystoscopy. The false-positive fluorescence-guided biopsy rate was 18/63 (29%).. HAL-PDD allows more complete management of bladder tumor in patients with multifocal recurrence. The high frequency of additional lesions detected and the rate of detection of CIS suggest that HAL-PDD should be the standard of care.

Topics: Adult; Aged; Aged, 80 and over; Aminolevulinic Acid; Biopsy; Carcinoma in Situ; Cystoscopy; Demography; Female; Humans; Male; Middle Aged; Muscles; Photosensitizing Agents; Recurrence; Urethra; Urinary Bladder; Urinary Bladder Neoplasms

We compared hexaminolevulinate fluorescence cystoscopy with white light cystoscopy for detecting Ta and T1 papillary lesions in patients with bladder cancer.. A total of 311 patients with known or suspected bladder cancer underwent bladder instillation with 50 ml 8 mM HAL for 1 hour. The bladder was inspected using white light cystoscopy, followed by blue light (fluorescence) cystoscopy. Papillary lesions were mapped and resected for histological examination.. Noninvasive pTa tumors were found in 108 of 196 evaluable patients (55.1%). In 31 patients (29%) at least 1 more tumor was detected by HAL than by white light cystoscopy (p<0.05). Six of these patients had no lesions detected by white light, 12 had 1 lesion detected by white light and more than 1 by HAL, and 13 had multiple Ta lesions detected by the 2 methods. Conversely at least 1 more tumor was detected by white light cystoscopy than by HAL cystoscopy in 10 patients (9%, 95% CI 5-16). Tumors invading the lamina propria (T1) were found in 20 patients (10.2%). At least 1 additional T1 tumor was detected by HAL but not by white light cystoscopy in 3 of these patients (15%), while at least 1 more T1 tumor was detected by white light cystoscopy than by HAL cystoscopy in 1 patient (5%, 95% CI 0-25). Detection rates for Ta tumors were 95% for HAL cystoscopy and 83% for white light cystoscopy (p=0.0001). Detection rates were 95% and 86%, respectively, for T1 tumors (p=0.3). HAL instillation was well tolerated with few local or systemic side effects.. HAL fluorescence cystoscopy detected at least 1 more Ta and T1 papillary tumor than white light cystoscopy in approximately a third of the patients with such tumors. Whether this would translate to improved patient outcomes has yet to be determined.

Topics: Aged; Aminolevulinic Acid; Carbon Radioisotopes; Carcinoma in Situ; Carcinoma, Transitional Cell; Cystoscopy; Female; Humans; Male; Middle Aged; Urinary Bladder Neoplasms

We compared hexaminolevulinate (Hexvix) fluorescence cystoscopy with white light cystoscopy for detecting carcinoma in situ.. In this multicenter study 298 patients with known or suspected bladder cancer underwent bladder instillation with 50 ml 8 mM hexaminolevulinate for 1 hour. Cystoscopy was then performed, first using standard white light and then hexaminolevulinate fluorescence cystoscopy. Lesions or suspicious areas identified under the 2 illumination conditions were mapped and biopsied for histological examination. In addition, 1 directed biopsy was obtained from an area appearing to be normal.. Of 196 evaluable patients 29.6% (58 of 196) had carcinoma in situ, including 18 with carcinoma in situ alone, and 35 with carcinoma in situ and concomitant papillary disease, which was only detected on random biopsy in 5. Of the 18 patients with no concomitant papillary disease carcinoma in situ was detected only by hexaminolevulinate fluorescence in 4 and only by white light in 4. In the group with concomitant papillary disease carcinoma in situ was found only by hexaminolevulinate fluorescence in 5 patients and only by white light in 3. The proportion of patients in whom 1 or more carcinoma in situ lesions were found only by hexaminolevulinate cystoscopy was greater than the hypothesized 5% (p=0.0022). Overall more carcinoma in situ lesions were found by hexaminolevulinate than by white light cystoscopy in 22 of 58 patients (41.5%), while the converse occurred in 8 of 58 (15.1%). Biopsy results confirmed cystoscopy findings. Of a total of 113 carcinoma in situ lesions in 58 patients 104 (92%) were detected by hexaminolevulinate cystoscopy and 77 (68%) were detected by white light cystoscopy, while 5 were detected only on directed visually normal mucosal biopsy. Hexaminolevulinate instillation was well tolerated with no local or systemic side effects.. In patients with bladder cancer hexaminolevulinate fluorescence cystoscopy with blue light can diagnose carcinoma in situ that may be missed with white light cystoscopy. Hexaminolevulinate fluorescence cystoscopy can be used in conjunction with white light cystoscopy to aid in the diagnosis of this form of bladder cancer.

Topics: Aged; Aminolevulinic Acid; Carbon Radioisotopes; Carcinoma in Situ; Cystoscopy; Female; Humans; Male; Middle Aged; Urinary Bladder Neoplasms

White light cystoscopy (WLC) is the standard procedure for visualising non-muscle invasive bladder cancer (NMIBC). However, WLC can fail to detect all cancerous lesions, and outcomes with transurethral resection of the bladder differ between institutions, controlled trials, and possibly between trials and routine application. This noninterventional study assessed the benefit of hexaminolevulinate blue light cystoscopy (HALC; Hexvix. From May 2013 to April 2014, 403 patients with suspected NMIBC were screened from 30 German centres to perform an unprecedented detailed assessment of the additional detection of cancer lesions with HALC versus WLC alone.. Among the histological results for 929 biopsy samples, 94.3 % were obtained from suspected cancerous lesions under either WLC or HALC: 59.5 % were carcinoma tissue and 40.5 % were non-cancerous tissue. Of all cancer lesions, 62.2 % were staged as Ta, 20.1 % as T1, 9.3 % as T2, 7.3 % as carcinoma in situ (CIS), and 1.2 % were unknown. Additional cancer lesions (+6.8 %) and CIS lesions (+25 %, p < 0.0001) were detected by HALC plus WLC versus WLC alone. In 10.0 % of patients, ≥1 additional positive lesion was detected with HALC, and 2.2 % of NMIBC patients would have been missed with WLC alone. No adverse events were observed.. The results of this study demonstrate that HALC significantly improves the detection of NMIBC versus WLC alone in routine clinical practice in Germany. While this benefit is statistically significant across all types of NMIBC, it seems most relevant in CIS.

Topics: Aged; Aged, 80 and over; Aminolevulinic Acid; Carcinoma in Situ; Carcinoma, Transitional Cell; Cystoscopy; Female; Germany; Humans; Male; Middle Aged; Muscle, Smooth; Neoplasm Grading; Neoplasm Invasiveness; Neoplasm Staging; Photosensitizing Agents; Urinary Bladder; Urinary Bladder Neoplasms

To compare the accuracy of white light cystoscopy (WLC) and blue light cystoscopy (BLC) in a cohort of patients undergoing radical cystectomy (RC) for previously resected urothelial bladder cancer.. A cohort of patients undergoing RC received WLC and BLC prior radical surgery. To evaluate the residual tumor rate, the bladder was inspected after its removal and normal appearing mucosa sampled for histologic analysis. Lesions detected under WLC, BLC, or both, and biopsy samples from normal appearing mucosa, were all recorded separately.. Starting 2011, 64 patients underwent WLC and BLC prior cystectomy. Overall, 540 tissue samples were collected during cystoscopy and from normal appearing mucosa. Residual disease was found in 31/64 (48.4%) patients, including 27 (42.1%) cases of carcinoma in situ (CIS). The accuracy of BLC was much higher than WLC, both in the diagnosis of any residual disease (87.1% vs 32.3%, and 87.9% vs 51.5%, for sensitivity and specificity, respectively), as of CIS only (92.6% vs 29.6% and 83.8% vs 51.4%). We further evaluated the diagnostic accuracy as a result of the analysis on all specimens collected during the study. A total of 535 specimens were analyzed, and 58 specimens with residual disease were found, including 48 CIS foci. Again, detection rates and measures of accuracy were much better for BLC vs WLC, both overall (86.2% vs 31%, and 98.3% vs 93.3%, for sensitivity and specificity, respectively), and when CIS only was considered (89.6% vs 31.2% and 96.9% vs 92.8%).. Although BLC missed 12.9% of positive patients, and 7.4% of those with CIS, the agreement between BLC diagnostic accuracy and the definitive pathology was very robust.

Topics: Adult; Aged; Aged, 80 and over; Aminolevulinic Acid; Carcinoma in Situ; Carcinoma, Transitional Cell; Cystectomy; Cystoscopy; Female; Humans; Light; Male; Middle Aged; Neoplasm, Residual; Photosensitizing Agents; Sensitivity and Specificity; Urinary Bladder Neoplasms

The authors evaluated the role of photodynamic cystoscopy in the detection of additional urothelial lesions, mainly carcinoma in situ, that would not be detected solely with white light cystoscopy, leading to disease understaging.. From 2009 to 2011, 70 patients underwent white light cystoscopy, followed by photodynamic cystoscopy (blue light system, Karl Storz, Tuttlingen, Germany). Preoperatively they were instilled intravesically with 50ml of Hexvix (Hexaminolevulinate hexylester). We recorded all lesions found with white light cystoscopy and the additional lesions revealed by blue light cystoscopy. Afterward all lesions were removed and sent for pathologic evaluation.. Seventeen patients (24.3%) had primary tumors while 53 patients (75.7%) had recurrent disease. In 53 out of 70 patients (75.7%) white light cystoscopy revealed urothelial lesions. In the rest 17 patients who had no findings with white light cystoscopy, blue light cystoscopy revealed 7 cases of Cis (41.2%) and 8 cases of dysplasia (47%). In the group of patients with visible lesions in white light cystoscopy photodynamic cystoscopy revealed additional carcinoma in situ in 22 patients. Altogether additional carcinoma in situ cases found with the aid of photodynamic cystoscopy were 29 out of 70 cases (41.4%).. Photodynamic cystoscopy is the most efficient diagnostic procedure for flat urothelial lesions and especially for carcinoma in situ. It is significantly more sensitive than conventional white light cystoscopy in Cis diagnosis, thus reducing understaging of the disease and consequently improving recurrence and progression rates.

Topics: Adult; Aged; Aged, 80 and over; Aminolevulinic Acid; Carcinoma in Situ; Cystoscopy; Female; Fluorescence; Humans; Male; Middle Aged; Neoplasm Staging; Photosensitizing Agents; Retrospective Studies; Urinary Bladder Neoplasms

In patients with non-muscle invasive bladder cancer, fluorescence cystoscopy can improve the detection and ablation of bladder tumors. In this paper we describe the technique and practical aspects of hexaminolevulinate (HAL) fluorescence cystoscopy, also known as "blue light cystoscopy".

Topics: Aminolevulinic Acid; Carcinoma in Situ; Cystoscopy; Fluorescence; Humans; Patient Selection; Urinary Bladder Neoplasms

Topics: Aminolevulinic Acid; Carcinoma in Situ; Diagnostic Techniques, Urological; False Positive Reactions; Humans; Male; Middle Aged; Photosensitizing Agents; Urinary Bladder Neoplasms

Therapeutic strategies on treatment of T1G3 urothelial cancer of the urinary bladder are controversial. The objective of this study was to investigate the impact of photodynamic diagnosis (PDD) on the recurrence-free survival rate of patients with the initial diagnosis of T1G3 bladder cancer.. Between 1995 and 2007, 153 patients were treated for T1G3 bladder cancer at our institution. In 77 patients, initial TUR-BT was performed under PDD condition at our hospital, and 76 patients underwent TUR-BT in a standard white light setting at other institutions. PDD was performed either using 5-aminolevulinate or hexaminolevulinate for induction of fluorescence. Average follow-up was 53.9 months. Fisher's exact test and Kaplan-Meier method were used to test data for significance.. Of the 77 patients who were treated using PDD at initial TUR-BT, recurrence was observed in 23 (29.9%) cases, whereas 43 of 76 (56.6%) patients treated without PDD showed recurrence (P < 0.001). The detection rate of additional carcinoma in situ was 35.4% in the PDD group versus 21.8% in the white light group (P = 0.077). A limitation of the present study is the retrospective, monocentre setting, which is more likely to be biased.. PDD during initial TUR-BT in T1G3 bladder cancer seems to reduce significantly the rate of recurrence in our study population. Therefore, PDD seems to be associated with superior initial tumour control and more effective tumour treatment even in patients with highly aggressive tumours like T1G3 bladder cancer.

Topics: Aged; Aminolevulinic Acid; Carcinoma in Situ; Cystoscopy; Female; Follow-Up Studies; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Neoplasm Recurrence, Local; Photosensitizing Agents; Prognosis; Retrospective Studies; Urinary Bladder Neoplasms

To investigate the value of photodynamic diagnosis (PDD) using hexylaminolaevulinate (Hexvix, PhotoCure, Oslo, Norway) in the investigation of patients with positive urine cytology who have no evidence of disease after standard initial investigations.. Twenty-three patients referred with positive urine cytology but no current histological evidence of cancer were investigated between April 2005 and January 2007 with PDD, using Hexvix and the D-light system (Karl Storz, Tuttlingen, Germany) to detect fluorescence. The bladder was mapped initially under white light and then under 'blue-light'. Biopsies were taken from abnormal urothelium detected by white light, fluorescence, or both. All cytological specimens were reviewed by a reference cytopathologist unaware of the result of the PDD.. Twenty-five PDD-assisted cystoscopies were carried out on 23 patients (20 men/3 women; median age 64 years, range 24-80 years). Of the 23 patients, 17 (74%) were previously untreated for transitional cell carcinoma (TCC), whilst six were under surveillance for previous TCC. Nineteen of the 23 (83%) cytology specimens were confirmed as suspicious or positive by the reference pathologist. TCC of the bladder or preneoplastic lesions were diagnosed in six patients, i.e. six (26%) of those investigated and six of 19 (32%) with confirmed positive cytology. Four of the six were under surveillance for previous bladder tumour. Additional pathology was detected by fluorescence in five of the six patients, including two carcinoma in situ (CIS), one CIS + G3pT1 tumour, and two dysplasia. Diagnoses in PDD-negative cases included one upper tract TCC and four patients with stones. In addition, one patient had CIS diagnosed on both white light and PDD 6 months later.. Additional pathology was detected by HAL fluorescence cystoscopy in 32% of patients with confirmed positive urinary cytology. PDD is a key step in the management of patients with positive urinary cytology and no evidence of disease on conventional tests.

Topics: Adult; Aged; Aged, 80 and over; Aminolevulinic Acid; Carcinoma in Situ; Carcinoma, Transitional Cell; Cohort Studies; Cystoscopy; Female; Humans; Male; Microscopy, Fluorescence; Middle Aged; Photosensitizing Agents; Predictive Value of Tests; Sensitivity and Specificity; Urinary Bladder Neoplasms; Young Adult

Topics: Aminolevulinic Acid; Carbon Radioisotopes; Carcinoma in Situ; Diagnostic Techniques, Urological; Forecasting; Humans; Reproducibility of Results; Urinary Bladder Neoplasms

Topics: Aminolevulinic Acid; Carcinoma in Situ; Clinical Trials, Phase III as Topic; Cystoscopy; Humans; Microscopy, Fluorescence; Multicenter Studies as Topic; Neoplasm Recurrence, Local; Photosensitizing Agents; Randomized Controlled Trials as Topic; Urinary Bladder Neoplasms

Fluorescence endoscopy is a promising new method for detection and treatment of premalignant and malignant lesions. The aim of this pilot study was to investigate the feasibility of hexaminolevulinate-based photodetection of rectal adenoma and cancer, including safety, dose finding, and efficacy.. Ten patients with known rectal adenoma or cancer were sensitized by instillation of 3.2 mM of hexaminolevulinate as an enema. Fluorescence endoscopy was performed after retention of the enema for 30 to 60 minutes, followed by a rest time of up to 30 minutes before endoscopy. Biopsy specimens were taken from fluorescent and non-fluorescent areas and fluorescence microscopy studies were performed to assess the distribution of protoporphyrin IX fluorescence in different tissue layers. Adverse events were reported by direct questioning of all patients; skin photosensitivity, changes in biochemical tests of liver function, blood pressure and heart rate, and the occurrence of GI symptoms (nausea, vomiting) were recorded for 5 patients.. Hexaminolevulinate-induced fluorescence endoscopy produced selective fluorescence of all rectal adenomas with intraepithelial neoplasia. For rectal cancer, there was only weak fluorescence or none at all. No hexaminolevulinate-induced side effect was observed. In two patients, fluorescence differentiated adenomas and hyperplastic polyps.. Hexaminolevulinate-based fluorescence endoscopy (3.2 mM administered as an enema) in patients with rectal cancer and adenoma was well tolerated and produced no significant skin sensitivity or other side effects. The optimal duration of application is 30 to 45 minutes, with a rest time of 30 minutes. Selective fluorescence of adenoma with intraepithelial neoplasia suggests that hexaminolevulinate-based fluorescence endoscopy may be useful for detection of premalignant lesions.

Topics: Adenoma; Aged; Aged, 80 and over; Aminolevulinic Acid; Biopsy; Carcinoma in Situ; Cell Transformation, Neoplastic; Colonic Polyps; Colonoscopy; Colorectal Neoplasms; Dose-Response Relationship, Drug; Feasibility Studies; Female; Fluorescent Dyes; Humans; Intestinal Mucosa; Male; Microscopy, Fluorescence; Middle Aged; Precancerous Conditions; Proctoscopy; Protoporphyrins