iotrex and Brain-Neoplasms

Balloon brachytherapy is a technique for the removal of a brain tumor in which an inflatable balloon is placed in a resection cavity and then filled with liquid I, delivering low energy dose to the cancerous cells surrounding the cavity. After preparing a patient room to mitigate any spills or contamination, liquid 125I (Iotrex) was assayed with a dose calibrator and injected into the balloon placed in the patient's brain. Approximately 98.6% of the isotope was recovered at the end of the procedure. Approximately 1.4% remained unrecovered and is assumed to have diffused through the balloon membrane. Each day, the patient's urine was collected and the total urine activity measured was less than 7% of the unrecovered activity. The remainder of the unrecovered activity was not evaluated. It was assumed to be distributed in the patient's body, and a tiny quantity of liquid spilled from an IV line while injecting. Training was conducted for radiation oncologists, neurosurgeons, and participating residents regarding balloon brachytherapy radiation safety precautions. Precautions during treatment included safe handling of body fluids. General radiation safety precautions and nursing care instructions were posted on the patient door. Air monitoring was conducted to detect any airborne iodine. At the time of balloon removal, the radiation safety department monitored the operating room and staff for contamination. Waste, including the balloon, was held for decay on site prior to disposal.

Topics: Benzenesulfonates; Brachytherapy; Brain Neoplasms; Humans; New Jersey

In this study, we assess the efficacy of GliaSite brachytherapy in the treatment of patients with recurrent glioblastoma multiforme (GBM).. Between 1999 and 2004, 24 patients with recurrent glioblastoma multiforme were treated with the GliaSite Radiation Therapy System (RTS). The GliaSite is an inflatable balloon catheter that is placed in the resection cavity at the time of surgical resection. Low-dose-rate radiation is then delivered locally by temporarily inflating the balloon with an aqueous solution of organically bound (125)I (Iotrex [sodium 3-((125)I)-iodo-4-hydroxybenzenesulfonate]). Patients at the Johns Hopkins Hospital with recurrent GBM, who were previously treated with surgery and external beam radiotherapy, underwent surgical resection followed by GliaSite balloon implantation. Subsequently, the patients received radiation therapy using the GliaSite to a mean dose of 53.1 Gy. Ten patients were male, and 14 patients were female. The mean age was 48.1 years. All patients had pathologically confirmed recurrent GBM. The median Karnofsky performance status (KPS) was 80. Median follow-up time was 21.8 months.. At the time of analysis, 18 patients (75%) had died; 6 patients (25%) were alive. Median survival from diagnosis for all patients was 23.3 months. Median survival after GliaSite brachytherapy was 9.1 months. Patients with a KPS > or =70 had a median survival of 9.3 months, whereas patients with a KPS <70 had a median survival of 3.1 months (p < 0.003). Survival was not significantly different between patients receiving 45 Gy and patients receiving a dose greater than 45 Gy. Acute side effects were minor, consisting of mild nausea and/or headache. One patient developed a wound infection. No incidents of meningitis were observed. Late sequelae were rare, but 2 incidents of symptomatic radiation necrosis were observed. One patient developed transient expressive aphasia.. GliaSite radiotherapy confers a prolongation of survival in patients with recurrent glioblastoma multiforme compared to historical controls with recurrent GBM. GliaSite therapy leads to a favorable survival outcome of 9.3 months in patients with KPS > or =70, but only 3.1 months in patients with KPS <70. Favorable survival is observed for patients within each recursive partitioning analysis class. Treatment with GliaSite is safe and generally well tolerated. Additional data are needed to fully assess the therapeutic benefit of GliaSite brachytherapy for recurrent GBM.

Topics: Adult; Aged; Benzenesulfonates; Brachytherapy; Brain Neoplasms; Combined Modality Therapy; Female; Glioblastoma; Humans; Iodine Radioisotopes; Male; Middle Aged; Neoplasm Recurrence, Local; Radiotherapy Dosage; Reoperation; Survival Rate

The GliaSite system delivers local, high radiation after brain tumor resection. We describe the imaging appearance of the device and the changes it causes.. Eight patients with brain tumors were treated with this system. After surgery, all underwent MR imaging, and one underwent CT. Five were examined 1 month after radioactive unloading and every 2 months thereafter (total, 6-9 months). Initial studies were assessed for balloon appearance and complications; subsequent studies, for signal intensity and enhancement. Three patients underwent multivoxel proton MR spectroscopy, and one underwent MR perfusion study. Spectra were reviewed for metabolites suggesting tumor; perfusion studies were reviewed for increased relative cerebral blood volume and flow.. CT showed the hyperattenuating balloon with considerable artifact. All MR images showed the device and adjacent brain. Follow-up studies showed enhancement and T2 hyperintensity in five patients. In one, enhancement progressively disappeared with no evidence of tumor recurrence. Another patient had progressive enhancement and low relative cerebral blood volume and flow; biopsy showed necrosis and inflammation. One patient had progressive enhancement and high choline levels (proved anaplastic astrocytoma). In another, T2 signal intensity and contrast enhancement progressed owing to tumor and bacterial infection. The last patient had a high choline level (proved radionecrosis); enhancement progressed over 5 months. In three, the device was removed early because of bleeding, mass effect, and therapeutic changes (no follow-up).. Good balloon visualization was possible with MR imaging. After brachytherapy, all patients developed T2 hyperintensity; stable or progressive enhancement occurred with tumor recurrence and radionecrosis. High choline levels were suggestive of, but not necessarily diagnostic of, tumor.

Topics: Aged; Astrocytoma; Benzenesulfonates; Blood Volume; Brachytherapy; Brain Neoplasms; Cerebral Cortex; Combined Modality Therapy; Contrast Media; Energy Metabolism; Equipment Design; Female; Follow-Up Studies; Glioblastoma; Humans; Image Processing, Computer-Assisted; Magnetic Resonance Imaging; Magnetic Resonance Spectroscopy; Male; Middle Aged; Radiation Injuries; Radiotherapy, Adjuvant; Radiotherapy, High-Energy; Regional Blood Flow; Retrospective Studies; Tomography, X-Ray Computed

The handling of a liquid radioactive source is a procedure that is uncommon for the average clinical medical physicist. A newly approved treatment device utilizes high activities of liquid I-125 solution as the source of radiation. The radiation safety issues and our experience utilizing high activity liquid I-125 sources are presented. To date we have treated 22 patients with infused activities ranging up to 26.8 GBq (724 mCi). The careful manipulation of such solutions is important to maintain a safe environment for the patients and the involved medical staff.

Topics: Benzenesulfonates; Brachytherapy; Brain Neoplasms; Catheterization; Equipment Safety; Humans; Iodine Radioisotopes; Occupational Health; Radiotherapy Dosage; Solutions; Time Factors

In this study the authors evaluated the safety and performance of the GliaSite Radiation Therapy System (RTS) in patients with recurrent malignant brain tumors who were undergoing tumor resection.. The GliaSite is an inflatable balloon catheter that is placed in the resection cavity at the time of tumor debulking. Low-dose-rate radiation is delivered with an aqueous solution of organically bound iodine-125 (lotrex [sodium 3-(125I)-iodo-4-hydroxybenzenesulfonate]), which are temporarily introduced into the balloon portion of the device via a subcutaneous port. Adults with recurrent malignant glioma underwent resection and GliaSite implantation. One to 2 weeks later, the device was filled with Iotrex for 3 to 6 days, following which the device was explanted. Twenty-one patients with recurrent high-grade astrocytomas were enrolled in the study and received radiation therapy. There were two end points: 1) successful implantation and delivery of brachytherapy; and 2) safety of the device. Implantation of the device, delivery of radiation, and the explantation procedure were well tolerated. At least 40 to 60 Gy was delivered to all tissues within the target volume. There were no serious adverse device-related events during brachytherapy. One patient had a pseudomeningocele, one patient had a wound infection, and three patients had meningitis (one bacterial, one chemical, and one aseptic). No symptomatic radiation necrosis was identified during 21.8 patient-years of follow up. The median survival of previously treated patients was 12.7 months (95% confidence interval 6.9-15.3 months).. The GliaSite RTS performs safely and efficiently. It delivers a readily quantifiable dose of radiation to tissue at the highest risk for tumor recurrence.

Topics: Adult; Aged; Benzenesulfonates; Brachytherapy; Brain Neoplasms; Catheterization; Catheters, Indwelling; Equipment Design; Feasibility Studies; Female; Glioma; Humans; Iodine Radioisotopes; Magnetic Resonance Imaging; Male; Middle Aged; Neoplasm Recurrence, Local; Neoplasm Staging; Radiation Dosage

The calibration of a liquid I-125 source in an older standard dose calibration system is presented. The calibration factor agrees well with factors established by the NIST for newer dose calibration systems. The determination of the source activity is necessary to accurately calculate the time required to deliver the prescribed dose.

Topics: Benzenesulfonates; Brachytherapy; Brain Neoplasms; Calibration; Humans; Iodine Radioisotopes; Syringes

Iotrex is an aqueous radiotherapy solution containing sodium 3-(125I)iodo-4-hydroxybenzenesulfonate (125I-HBS), which is used as the radiation source for the brachytherapy of resected of brain tumor cavity margins with the GliaSite catheter. During routine clinical use of this brachytherapy applicator and radiation source, approximately 0.1% of the afterloaded Iotrex will diffuse through the GliaSite balloon. Our purpose was to assess the radiation doses to normal organs under routine clinical use of the GliaSite.. Five groups of rats received intracerebral injections of an 131I-HBS solution (131I used as a surrogate for 125I in the synthesis of 125I-HBS) with one group sacrificed at 15 minutes, 30 minutes, 1 hour, 2 hours and 4 hours post-administration. Urine was collected and activity retention in numerous organs was measured. The biodistribution data were used to estimate radiation doses to normal organs of the Reference Adult Male and Female phantoms.. Radioactivity was rapidly and completely cleared from the brain (98% cleared by 2 hours) and total body (urinary clearance; 93%@2 hours). No organ retained > 0.7% of the radioactivity at 4 hours. For 100% loss of the radiotherapy solution from the balloon catheter (device failure), all organs would receive less than 100 mGy (10 rad), except the bladder wall (2800 mGy, 280 rad), uterus (130 mGy, 13 rad) and distal colon (270 mGy, 27 rad). Under normal conditions, all organ doses are 1000-fold lower (< 3 mGy or 0.3 rad).. Under routine clinical conditions, the radiation doses to normal organs are inconsequential. Should the maximum clinical load of Iotrex (16.7 GBq of 125I) be released intracerebrally, the radiation doses to all organs would be below the thresholds for deterministic effects.

Topics: Animals; Benzenesulfonates; Brachytherapy; Brain; Brain Neoplasms; Male; Models, Statistical; Radiometry; Rats; Rats, Sprague-Dawley; Tissue Distribution