GammaTile® for Brain Tumors
(ENDURANCE Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests GammaTile®, a treatment option for elderly or frail individuals with certain types of brain tumors, specifically malignant gliomas. The goal is to determine if GammaTile® is safe and effective for people with newly diagnosed or recurring brain tumors. Participants should have a measurable brain tumor that doctors believe can be mostly removed through surgery. The treatment targets those with a tumor visible on scans who meet specific surgical criteria. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.
What prior data suggests that GammaTile® is safe for treating brain tumors?
Research has shown that GammaTile® is generally safe and well-tolerated. In one study, only 1 out of 74 patients experienced hair loss. Another study found no unexpected results when experienced doctors used it. Early data also suggests that it can be a safe type of radiation therapy for patients with recurring brain tumors. Overall, these findings suggest that GammaTile® has a promising safety profile, especially for those with challenging conditions like gliomas.12345
Why do researchers think this study treatment might be promising for brain tumors?
Researchers are excited about GammaTile® for brain tumors because it offers a unique way to deliver radiation therapy directly to the tumor site. Unlike traditional radiation treatments that require multiple hospital visits, GammaTile® is implanted during surgery, providing targeted therapy right where it's needed most. This localized approach helps to minimize exposure to surrounding healthy brain tissue, potentially reducing side effects. Additionally, the immediate delivery of radiation post-surgery may improve outcomes in elderly or frail patients who might not tolerate conventional treatments well.
What evidence suggests that GammaTile® might be an effective treatment for brain tumors?
Research has shown that GammaTile® can help treat brain tumors like glioblastoma. This trial will evaluate GammaTile® in various contexts, including newly diagnosed and recurrent cases of glioblastoma and other malignant gliomas in elderly or frail patients. Studies have found that GammaTile® delivers radiation directly to the tumor, helping to control its growth and potentially improve survival rates. Specifically, for some patients with recurring glioblastoma, previous treatments with GammaTile® resulted in a median survival time of up to 21 months. This is significant because survival rates for these aggressive tumors are usually low. The treatment is promising because it begins working immediately, delivering radiation right after placement during surgery.678910
Who Is on the Research Team?
Carlen Yuen, MD
Principal Investigator
Chao Family Comprehensive Cancer Center
Are You a Good Fit for This Trial?
This trial is for elderly or frail adults who have just been diagnosed with, or have a recurrence of, malignant brain tumors like glioblastoma or astrocytoma. Participants must be considered too old or weak for standard treatments.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive GammaTile® for treatment of newly diagnosed or recurrent malignant gliomas
Follow-up
Participants are monitored for safety and effectiveness after treatment
Long-term follow-up
Participants are monitored for progression-free survival and overall survival
What Are the Treatments Tested in This Trial?
Interventions
- GammaTile®
Trial Overview
The study is testing GammaTile®, a small implant that delivers radiation directly to the brain tumor site during surgery. The goal is to see if this treatment is safe and manageable in older or frail patients.
How Is the Trial Designed?
4
Treatment groups
Experimental Treatment
GammaTile®
GammaTile®
GammaTile®
GammaTile®
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of California, Irvine
Lead Sponsor
GT Medical Technologies, Inc.
Industry Sponsor
Citations
First application of GammaTile cesium-131 brachytherapy ...
Here, we report clinical outcomes for recurrent glioblastoma patients after GT treatment following maximal safe resection. Methods We ...
Brain Tumor News
Median overall survival was 13 months with the 2-week schedule versus 21 months with the standard schedule. The 6 × 6 Gy regimen also produced more radiation ...
Intracranial Brachytherapy for Primary CNS Tumors
As a result, high-grade gliomas are associated with a poor prognosis and necessitate intensive treatment [8–10]. Survival for these types of tumors is grim, ...
Beginning Radiation Immediately With GammaTile at GBM ...
This is a Phase 3 prospective, randomized, superiority, open-label, multi-site study. The overview of this study is as follows:A Screening/Baseline Period ...
Radiotherapy is Associated With Global Methylation Alterations ...
radiation treatment interruption due to skin AEs. Other Grade 1 events included pruritus (33.3%), fatigue (30%), nausea (13.3%), headache.
Cross-trial Evidence of Safety, Efficacy, and Immune Activation ...
Recurrent glioblastoma (rGBM) remains a devastating diagnosis, with limited therapeutic options and a median post-progression survival of 6–9 months.
CTNI-75. TRIALS IN PROGRESS: REGISTRY OF SAFETY ...
No unexpected outcomes reported in the hands of experienced providers have occurred, used to benchmark clinical outcomes of R+STaRT therapy
Beginning Radiation Immediately With GammaTile at GBM ...
Summary. This is a Phase 3 prospective, randomized, superiority, open-label, multi-site study. The overview of this study is as follows:
Phase II Elderly/Frail Pts With Newly Diagnosed or ...
GammaTile 28 days. Safety and tolerability will be determined by the proportion, nature, and severity of treatment-related adverse events … laboratory tests, ...
10.
centerwatch.com
centerwatch.com/clinical-trials/listings/NCT05900908/post-operative-adjuvant-therapy-w-wo-gammatile-systemic-therapyPost-operative Adjuvant Therapy w/wo GammaTile + Systemic ...
To compare surgical tumor removal and GammaTile therapy followed by adjuvant systemic therapy (bevacizumab or lomustine) to surgical tumor removal followed ...
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.