Cs-131 Brachytherapy for Recurrent Brain Cancer
Recruiting in Palo Alto (17 mi)
+7 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: Memorial Sloan Kettering Cancer Center
Disqualifiers: Pregnancy, Leptomeningeal carcinomatosis, Immunodeficiency, others
No Placebo Group
Prior Safety Data
Trial Summary
What is the purpose of this trial?The purpose of this study is to see if Cs-131 brachytherapy is effective in people with recurrent brain cancer who are scheduled to have brain surgery for removal of their tumor(s). The researchers would like to see whether Cs-131 prevents brain tumors from growing back after surgery.The researchers will compare Cs-131 brachytherapy (which occurs during brain surgery) with the usual approach of brain surgery without brachytherapy. The researchers will compare both the effectiveness and safety of the two approaches.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the treatment Cs-131 Brachytherapy for Recurrent Brain Cancer?
Research shows that Cs-131 brachytherapy can provide durable local control of brain tumors that have recurred after previous radiation treatments, with a 1-year local control rate of 83.3% and minimal side effects. This suggests it is a safe and effective option for patients with recurrent brain cancer.
12345Is Cs-131 brachytherapy safe for humans?
Research shows that Cs-131 brachytherapy is generally safe for treating brain tumors, with limited radiation exposure to patients, family, and medical staff. Safety measures and guidelines ensure that radiation levels remain low, making it a safe option for brain cancer treatment.
23567How is Cs-131 brachytherapy different from other treatments for recurrent brain cancer?
Cs-131 brachytherapy is unique because it involves placing radioactive seeds directly into the brain during surgery, providing targeted radiation to the tumor site. This approach minimizes radiation exposure to surrounding healthy tissue and reduces the risk of radiation-induced complications compared to traditional whole-brain radiotherapy, which is delivered over several days and can cause more side effects.
12346Eligibility Criteria
This trial is for adults over 18 with recurrent brain cancer who can consent, are able to have an MRI, and are scheduled for brain surgery. They should be in good enough health to perform daily activities (KPS ≥70) and not pregnant or breastfeeding. Excluded are those with infections, immunodeficiency, urgent surgery needs, more than six active brain lesions, intolerance to MRI/CT scans or excessive prior radiation.Inclusion Criteria
I am able to care for myself but may not be able to do active work.
I am scheduled for surgery to remove a brain tumor that was previously treated with radiation.
You are able to have a brain MRI with a special dye called gadolinium.
+1 more
Exclusion Criteria
I do not have an active infection or a weak immune system.
You can't handle MRI or CT scans.
Women must agree to not breastfeed for at least 12 weeks after the procedure (lactating and discarding in that interval allowable)
+5 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants undergo craniotomy with or without Cs-131 brachytherapy during brain surgery
Immediate (during surgery)
Follow-up
Participants are monitored for safety and effectiveness after treatment, including MRI scans and physical examinations
9 months
Participant Groups
The study tests if Cs-131 brachytherapy during brain surgery helps prevent tumor regrowth compared to standard surgery without it. It's a randomized Phase II trial where the effectiveness and safety of adding Cs-131 at the time of tumor removal will be evaluated against usual surgical care.
2Treatment groups
Experimental Treatment
Active Control
Group I: Resection plus brachytherapyExperimental Treatment2 Interventions
Patients will undergo craniotomy and patients in the treatment arm will undergo implantation of Cesium 131 brachytherapy in coordination with the radiation oncologist.
Group II: Resection without brachytherapyActive Control1 Intervention
Patients will undergo craniotomy.
Cesium-131 brachytherapy is already approved in United States for the following indications:
🇺🇸 Approved in United States as Cs-131 brachytherapy for:
- Brain metastases
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Memorial Sloan Kettering Monmouth (Consent Only)Middletown, NJ
Baptist Health South FloridaMiami, FL
Memorial Sloan Kettering Commack (Consent Only)Commack, NY
Henry Ford HospitalDetroit, MI
More Trial Locations
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Who Is Running the Clinical Trial?
Memorial Sloan Kettering Cancer CenterLead Sponsor
GT Medical Technologies, Inc.Industry Sponsor
References
Cesium-131 brachytherapy for recurrent brain metastases: durable salvage treatment for previously irradiated metastatic disease. [2019]OBJECTIVE Managing patients whose intraparenchymal brain metastases recur after radiotherapy remains a challenge. Intraoperative cesium-131 (Cs-131) brachytherapy performed at the time of neurosurgical resection may represent an excellent salvage treatment option. The authors evaluated the outcomes of this novel treatment with permanent intraoperative Cs-131 brachytherapy. METHODS Thirteen patients with 15 metastases to the brain that recurred after stereotactic radiosurgery and/or whole brain radiotherapy were treated between 2010 and 2015. Stranded Cs-131 seeds were placed as a permanent volume implant. Prescription dose was 80 Gy at 5-mm depth from the resection cavity surface. The primary end point was resection cavity freedom from progression (FFP). Resection cavity freedom from progression (FFP), regional FFP, distant FFP, median survival, overall survival (OS), and toxicity were assessed. RESULTS The median duration of follow-up after salvage treatment was 5 months (range 0.5-18 months). The patients' median age was 64 years (range 51-74 years). The median resected tumor diameter was 2.9 cm (range 1.0-5.6 cm). The median number of seeds implanted was 19 (range 10-40), with a median activity per seed of 2.25 U (range 1.98-3.01 U) and median total activity of 39.6 U (range 20.0-95.2 U). The 1-year actuarial local FFP was 83.3%. The median OS was 7 months, and 1-year OS was 24.7%. Complications included infection (3), pseudomeningocele (1), seizure (1), and asymptomatic radionecrosis (RN) (1). CONCLUSIONS After failure of prior irradiation of brain metastases, re-irradiation with intraoperative Cs-131 brachytherapy implants provides durable local control and limits the risk of RN. The authors' initial experience demonstrates that this treatment approach is well tolerated and safe for patients with previously irradiated tumors after failure of more than 1 radiotherapy regimen and that it results in excellent response rates and minimal toxicity.
The role of cesium-131 brachytherapy in brain tumors: a scoping review of the literature and ongoing clinical trials. [2022]Cesium-131 radioactive isotope has favored the resurgence of intracavitary brachytherapy in neuro-oncology, minimizing radiation-induced complications and maximizing logistical and clinical outcomes. We reviewed the literature on cesium-131 brachytherapy for brain tumors.
Surgical Technique and Clinically Relevant Resection Cavity Dynamics Following Implantation of Cesium-131 (Cs-131) Brachytherapy in Patients With Brain Metastases. [2019]Cesium-131 (Cs-131) brachytherapy is used to reduce local recurrence of resected brain metastases. In order to ensure dose homogeneity and reduce risk of radiation necrosis, inter-seed distance and cavity volume must remain stable during delivery.
Phase I/II study of resection and intraoperative cesium-131 radioisotope brachytherapy in patients with newly diagnosed brain metastases. [2022]Resected brain metastases have a high rate of local recurrence without adjuvant therapy. Adjuvant whole-brain radiotherapy (WBRT) remains the standard of care with a local control rate > 90%. However, WBRT is delivered over 10-15 days, which can delay other therapy and is associated with acute and long-term toxicities. Permanent cesium-131 ((131)Cs) implants can be used at the time of metastatic resection, thereby avoiding the need for any additional therapy. The authors evaluated the safety, feasibility, and efficacy of a novel therapeutic approach with permanent (131)Cs brachytherapy at the resection for brain metastases.
Safety and efficacy of Cesium-131 brachytherapy for brain tumors. [2023]The introduction of Cesium-131 (Cs-131) as a radiation source has led to a resurgence of brachytherapy for central nervous system (CNS) tumors. The aim of this study was to evaluate the safety and efficacy of the largest cohort of Cs-131 patients to-date.
Patient-specific radiological protection precautions following Cs collagen embedded Cs-131 implantation in the brain. [2022]Cesium-131 brachytherapy is an adjunct for brain tumor treatment, offering potential clinical and radiation protection advantages over other isotopes including iodine-125. We present evidence-based radiation safety recommendations from an initial experience with Cs-131 brachytherapy in the resection cavities of recurrent, previously irradiated brain metastases.
Radiation Exposure and Safety Precautions Following 131Cs Brachytherapy in Patients with Brain Tumors. [2022]Cesium-131 (Cs) brachytherapy is a safe and convenient treatment option for patients with resected brain tumors. This study prospectively analyzes radiation exposure in the patient population who were treated with a maximally safe neurosurgical resection and Cs brachytherapy. Following implantation, radiation dose rate measurements were taken at the surface, 35 cm, and 100 cm distances. Using the half-life of Cs (9.69 d), the dose rates were extrapolated at these distances over a period of time (t = 30 d). Data from dosimetry badges and rings worn by surgeons and radiation oncologists were collected and analyzed. Postoperatively, median dose rate was 0.2475 mSv h, 0.01 mSv h, and 0.001 mSv h and at 30 d post-implant, 0.0298 mSv h, 0.0012 mSv h, and 0.0001 mSv h at the surface, 35 cm, and 100 cm, respectively. All but one badge and ring measured a dose equivalent corresponding to ~0 mSv h, while 1 badge measured 0.02/0.02/0.02 mSv h. There was a significant correlation between the number of seeds implanted and dose rate at the surface (p = 0.0169). When stratified by the number of seeds: 4-15 seeds (n = 14) and 20-50 seeds (n = 4) had median dose rates of 0.1475 mSv h and 0.5565 mSv h, respectively (p = 0.0015). Using National Council on Radiation Protection guidelines, this study shows that dose equivalent from permanent Cs brachytherapy for the treatment of brain tumors is limited, and it maintains safe levels of exposure to family and medical personnel. Such information is critical knowledge for the neurosurgeons, radiation oncologists, nurses, hospital staff, and family as this method is gaining nationwide popularity.