Clinical trials
GammaTile® brain tumor
clinical trials
GammaTile is FDA-cleared for patients with newly diagnosed malignant (cancerous) brain tumors and patients with recurrent brain tumors, with ongoing clinical trials to further support its effectiveness.
Explore detailed information about ongoing GammaTile clinical trials for brain tumors, including eligibility, enrollment steps, and trial-specific FAQs at the trial links below.
Brain tumor clinical trials:
Newly diagnosed
brain mets
ROADS Randomized Clinical Trial (RCT)
ClinicalTrials.gov ID: NCT04365374
For patients with newly diagnosed brain metastases eligible for surgery.
The ROADS Clinical Trial is a randomized clinical trial that compares two types of radiation therapy used after surgery for treating newly diagnosed brain metastases: GammaTile therapy and Post-Surgical Stereotactic Radiotherapy (SRT). The goal of the ROADS study is to establish whether GammaTile is as effective as conventional methods (SRT) in preventing tumor recurrence after surgical resection, while maintaining a comparable safety profile and minimizing the impact on patients’ quality of life.
Study Sponsor: GT Medical Technologies
Lead Institution: The University of Texas – MD Anderson Cancer Center
Find answers to common questions about the ROADS Randomized Clinical Trial, including eligibility, enrollment, participating sites, safety, and what to expect during participation.
Brain tumor clinical trials:
Recurrent
brain mets
Intracavity Carrier-embedded Cs-131 Brachy for Recurrent Mets: a Randomized Phase II Study
ClinicalTrials.gov ID: NCT04690348
For patients with recurrent brain metastases eligible for surgery.
The purpose of this study is to see if Cs-131 brachytherapy (GammaTile) is effective in people with recurrent brain metastases 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. They will compare the effectiveness and safety of Cs-131 brachytherapy (placed at the time of surgery) with the usual standard approach of brain surgery without brachytherapy.
Study Sponsor: Memorial Sloan Kettering Cancer Center
Lead Institution: Memorial Sloan Kettering Cancer Center
Find answers to common questions about the Intracavity Carrier-embedded Cs-131 Brachy for Recurrent Mets: a Randomized Phase II Study, including eligibility, enrollment, participating sites, safety, and what to expect during participation.
Brain tumor clinical trials:
Newly diagnosed
glioblastoma
GESTALT Clinical Trial
ClinicalTrials.gov ID: NCT05342883
For patients with newly diagnosed glioblastomas (GBMs).
The GESTALT Clinical Trial is evaluating a new approach to treating glioblastoma (GBM) by adding GammaTile radiation therapy to the standard treatment of care, external beam radiation (EBRT), and chemotherapy. Unlike traditional treatment, which delays radiation until after healing from surgery, GammaTile is placed at the time of surgery, beginning targeted radiation immediately. This trial aims to determine whether combining immediate GammaTile therapy with standard post-operative radiation and chemotherapy is a feasible, safe, and effective treatment for GBM patients.
Study Sponsor: GT Medical Technologies
Find answers to common questions about the GESTALT Clinical Trial, including eligibility, enrollment, participating sites, safety, and what to expect during participation.
Brain tumor clinical trials:
All GammaTile
brain tumor types*
Registry of Patients with Brain Tumors Treated With STaRT (GammaTiles)
ClinicalTrials.gov ID: NCT04427384
For patients with brain tumors treated with GammaTile.
The objectives of this registry study are to evaluate real-world clinical outcomes and patient reported outcomes that measure the effectiveness and safety of STaRT (GammaTile).
Study Sponsor: GT Medical Technologies
Find answers to common questions about the GammaTile Registry, including eligibility, enrollment, participating sites, safety, and what to expect during participation.
Understanding
brain tumor clinical trials:
Find answers to common questions about clinical trials for brain tumors, including eligibility, enrollment, safety, and what to expect during participation.