GlioblastomaPhase 3BRIDGESNCT07195591
Beginning Radiation Immediately With GammaTile at GBM Excision Versus Standard of Care
A Phase 3 study testing GammaTile®, External Beam Radiation Therapy and Temozolomide in people with Glioblastoma, run by GT Medical Technologies, Inc. at 13 sites in United States.
Trial summary
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 of 21 days. During this time, patients will be randomized into a 1:2 allocation of Arm A:Arm B. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma
- What is being tested?
- GammaTile®, External Beam Radiation Therapy and Temozolomide
- Type of treatment
- Pill or oral medicine, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 766 participants
- Where
- 13 sitesUnited States
- Study dates
- 10 Dec 2025to Dec 2031
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must be ≥18 years of age.
- Have radiographic suspicion of newly diagnosed glioblastoma (GBM).
- o If final pathology reports IDH mutant glioma, then the patients found to have an IDH mutation will be followed for safety and QoL measures but will not be included in the primary and secondary comparative survival and efficacy analyses.
- Are medically and surgically appropriate for resection.
- Have an estimated Karnofsky Performance Scale (KPS) score of ≥70.
- Are able to receive standard of care treatment.
Who cannot join
- A previous biopsy diagnosis other than IDH wild-type GBM.
- Have contraindications to TMZ, magnetic resonance imaging, gadolinium, or non-contrast computed tomography.
- Have multi-focal enhancing tumors that cannot be encompassed in one operative field.
Trial locations and contacts
13 sites in 1 country. Contact the study team or a site near you to ask about taking part.
13 sites in 1 country
United States13 sites, 13 recruiting
- Recruiting
Emory Winship Cancer Institute
Atlanta, Georgia, 30322
Winship Clinical Trial Office, 404-778-1868, winshipcto@emory.edu
Kimberly B. Hoang, MD
- Recruiting
Johns Hopkins University
Baltimore, Maryland, 21287
Jordina Rincon-Torroella, MD, 410-955-1040, jrincon2@jhmi.edu
Jordina Rincon-Torroella, MD
- Recruiting
The Ohio State University
Columbus, Ohio, 43210
James B Elder, MD
James B Elder, MD
- Recruiting
Inova Schar Cancer Institute
Fairfax, Virginia, 22031
Kevin Choe, MD, PhD
Kevin Choe, MD, PhD
- Recruiting
East Carolina University
Greenville, North Carolina, 27834
Shayla Vickers, RN, Shayla.Vickers@ecuhealth.org
K. Stuart Lee, MD
- Recruiting
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03766
Cancer Research Nurse, cancer.research.nurse@hitchcock.org
Linton Evans, MD
- Recruiting
Keck Medicine of USC
Los Angeles, California, 90033
Lorraine Martinez Seng, BSN, RN, Lorraine.Martinez@med.usc.edu
Eric Chang, MD
- Recruiting
Jersey Shore University Medical Center | Hackensack
Neptune City, New Jersey, 07753
Diane Doherty, MSN, RN-BC, OCN, diane.doherty@hmhn.org
Nitesh Patel, MD
- Recruiting
Advent Health
Orlando, Florida, 32804
Jack Ramsberger, jack.ramsberger@adventhealth.com
Imran Mohiuddin, MD, PhD
- Recruiting
Allegheny Health Network
Pittsburgh, Pennsylvania, 15212
Sarah Kimutis, 724-228-1414, Sarah.Kimutis@ahn.org
Matthew Shepard, MD
- Recruiting
Brown University Health
Providence, Rhode Island, 02903
Maria Duffy, mduffy@brownhealth.org
Clark Chen, MD, PhD
- Recruiting
HonorHealth Scottsdale Osborn Medical Center
Scottsdale, Arizona, 85251
Maria Canchola, BSN, RN-BC, mcanchola@honorhealth.com
John Wanebo, MD
- Recruiting
Westchester Medical Center
Valhalla, New York, 10595
Cristina Falo, PhD, Cristina.Falo@wmchealth.org
Simon Hanft, MD
About this study
Official title: Randomized Study of Resection and GammaTile® Followed by Concurrent External Beam Radiation Therapy (EBRT) and Temozolomide (TMZ) and Adjuvant TMZ Versus Standard of Care in Newly Diagnosed Glioblastoma (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 of 21 days. During this time, patients will be randomized into a 1:2 allocation of Arm A:Arm B.
- A Perioperative/Operative Phase where patients will undergo tumor resection (Arm A) or tumor resection plus GammaTile implantation (Arm B).
- An EBRT Prior to Start Period. This occurs within 10 business days prior to EBRT and Concurrent TMZ Phase.
- An EBRT and Concurrent TMZ Phase, which will begin 30 ±10 days post-surgery. EBRT (30 fractions) and TMZ will be administered up to 5 days a week for 6 weeks in Arm A, and EBRT (20 fractions) and TMZ will be administered for up to 5 days a week for 4 weeks in Arm B. TMZ will be administered at a dose of 75 mg/m2/day orally for each Arm.
- An Adjuvant TMZ Phase, which begins 28 ±7 days following the EBRT and Concurrent TMZ Phase, and is comprised of six 28-day cycles. TMZ (150-200 mg/m2/day orally) will be administered for the first 5 days of each 28-day cycle for each Arm. Tumor treating fields are allowed but are not mandated during this phase. Up to 6 additional cycles (for a total of 12) can be completed at the discretion of the Investigator.
- An Early Discontinuation/Follow-Up Phase will occur 28 ±7 days after completion of Cycle 6 of the Adjuvant TMZ Phase, regardless of the total number of cycles completed or any delays in cycle start. If fewer than six cycles are completed, the first follow-up assessment will occur 28 ±7 days after the last administered dose of adjuvant TMZ. If patient has a qualifying event requiring entrance to Early Discontinuation Phase, the first follow-up assessment will occur as soon as feasible, but within 28 days.
For any unscheduled visits, data collected should be documented in the case report form (CRF) and must include, but are not limited to, safety evaluations, survival status, and disease status.
- Conditions
- Glioblastoma
- Being tested
- GammaTile®, External Beam Radiation Therapy, Temozolomide
- Keywords
- Glioblastoma, Newly Diagnosed, GammaTile, External Beam Radiation Therapy, Temozolomide, Brain, Tumor, Brachytherapy, Radiation Therapy, Surgery, Resection, GBM, BRIDGES, EBRT, TMZ
- Medical subject headings
- Glioblastoma, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GammaTile®Device
GammaTiles are a U.S. FDA-cleared, surgically targeted radiation therapy for patients with certain brain tumors. GammaTile consists of bioresorbable collagen tiles embedded with Cesium-131 (Cs-131) radioactive seeds
External Beam Radiation TherapyRadiation
Also called EBRT
External beam radiation therapy (EBRT) is a type of radiation therapy that is standard of care. EBRT uses a machine outside the body to deliver high-energy beams of radiation to cancerous areas within the body
TemozolomideDrug
Also called TMZ
TMZ (Chemotherapy) is used as a first-line treatment, often in combination with radiation therapy after surgical resection of the tumor
| Study group | Role | What they receive |
|---|---|---|
| Maximal safe resection followed by EBRT with concurrent TMZ followed by adjuvant TMZ (Arm A) | Active comparator | All patients will undergo tumor resection. Start TMZ (75 mg/m2/day orally) on the first day of EBRT and will be administered concurrently with EBRT, up to 5 days per week, for the 30-fraction course of EBRT for 6 weeks within 30±10 days post-surgery. After EBRT and concurrent TMZ phase, the first cycle begins 28 ±7 days following the last day of the EBRT and Concurrent TMZ Phase. Adjuvant TMZ includes 5 days of TMZ treatment at the start of each 28-day cycle. Additional cycles (up to a maximum of 12), which may be given at the discretion of the Investigator, will be documented, and performed in the same manner as done in the first 6 cycles. Receives: Radiation: External Beam Radiation Therapy; Drug: Temozolomide |
| Maximal safe resection + GammaTile followed by EBRT with concurrent TMZ then adjuvant TMZ (Arm B) | Experimental | All patients will undergo tumor resection + GammaTile implantation. Start TMZ (75 mg/m2/day orally) on the first day of EBRT and will be administered concurrently with EBRT, up to 5 days per week, for the 20-fraction course of EBRT for 4 weeks within 30±10 days post-surgery. After EBRT and concurrent TMZ phase, the first cycle begins 28 ±7 days following the last day of the EBRT and Concurrent TMZ Phase. Adjuvant TMZ includes 5 days of TMZ treatment at the start of each 28-day cycle. Additional cycles (up to a maximum of 12), which may be given at the discretion of the Investigator, will be documented, and performed in the same manner as done in the first 6 cycles. Receives: Device: GammaTile®; Radiation: External Beam Radiation Therapy; Drug: Temozolomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival
The primary endpoint of the study is OS, defined as the day from surgery to death. Patients who are still alive (or lost to follow-up) at the time of data analysis will be censored at the last time point they were known to be alive.
Measured: Days from surgery to death.
Secondary outcomes (5)
Progression Free Survival
To compare PFS, defined as days from surgery to death or disease progression, between the 2 study arms based on the most current RANO Resect Group criteria;
Measured: Days from surgery to death or disease progression.
Time to next unplanned treatment
To compare the time to next unplanned treatment per study arm
Measured: Time to next unplanned treatment.
Performance Status
To assess the performance status up to 24 months
Measured: 24 months.
Safety Assessment
To assess the nature, severity, and frequency of AEs between the 2 study arms based on the most current CTCAE criteria
Measured: Study duration.
Quality of Life Assessments
Financial toxicity scale (Comprehensive Score for Financial Toxicity [COST]-score) and functional assessment of cancer therapy - brain (FACT-Br) up to 12 months after randomization.
Measured: COST-Score duration of study; FACT-Br up to 12 months after randomization.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2025
- Study start10 Dec 2025
- Primary completionDec 2031 (estimated)
- Study completionDec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlioblastomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 766 participants (estimated)
Sponsor and investigators
- Lead sponsor
- GT Medical Technologies, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07195591
- Sponsor's protocol ID
- GTM-105
- Acronym
- BRIDGES
- Status last verified
- Oct 2026
- First submitted
- 10 Sep 2025
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Study of Resection and GammaTile® Followed by Concurrent External Beam Radiation Therapy (EBRT) and Temozolomide (TMZ) and Adjuvant TMZ Versus Standard of Care in Newly Diagnosed Glioblastoma (GBM)
- ClinicalTrials.gov ID
- NCT07195591
- Acronym / sponsor ID
- BRIDGES / GTM-105
- Conditions
- Glioblastoma
- Keywords
- Glioblastoma, Newly Diagnosed, GammaTile, External Beam Radiation Therapy, Temozolomide, Brain, Tumor, Brachytherapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 766 participants (estimated)
- Lead sponsor
- GT Medical Technologies, Inc.Industry (pharma, biotech, devices)
- Study start
- 10 Dec 2025 (actual)
- Primary completion
- Dec 2031 (estimated)
- Study completion
- Dec 2031 (estimated)
- First posted
- 26 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 of 21 days. During this time, patients will be randomized into a 1:2 allocation of Arm A:Arm B.
- A Perioperative/Operative Phase where patients will undergo tumor resection (Arm A) or tumor resection plus GammaTile implantation (Arm B).
- An EBRT Prior to Start Period. This occurs within 10 business days prior to EBRT and Concurrent TMZ Phase.
- An EBRT and Concurrent TMZ Phase, which will begin 30 ±10 days post-surgery. EBRT (30 fractions) and TMZ will be administered up to 5 days a week for 6 weeks in Arm A, and EBRT (20 fractions) and TMZ will be administered for up to 5 days a week for 4 weeks in Arm B. TMZ will be administered at a dose of 75 mg/m2/day orally for each Arm.
- An Adjuvant TMZ Phase, which begins 28 ±7 days following the EBRT and Concurrent TMZ Phase, and is comprised of six 28-day cycles. TMZ (150-200 mg/m2/day orally) will be administered for the first 5 days of each 28-day cycle for each Arm. Tumor treating fields are allowed but are not mandated during this phase. Up to 6 additional cycles (for a total of 12) can be completed at the discretion of the Investigator.
- An Early Discontinuation/Follow-Up Phase will occur 28 ±7 days after completion of Cycle 6 of the Adjuvant TMZ Phase, regardless of the total number of cycles completed or any delays in cycle start. If fewer than six cycles are completed, the first follow-up assessment will occur 28 ±7 days after the last administered dose of adjuvant TMZ. If patient has a qualifying event requiring entrance to Early Discontinuation Phase, the first follow-up assessment will occur as soon as feasible, but within 28 days.
For any unscheduled visits, data collected should be documented in the case report form (CRF) and must include, but are not limited to, safety evaluations, survival status, and disease status.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Maximal safe resection followed by EBRT with concurrent TMZ followed by adjuvant TMZ (Arm A) | Active comparator | Radiation: External Beam Radiation Therapy, Drug: TemozolomideAll patients will undergo tumor resection. Start TMZ (75 mg/m2/day orally) on the first day of EBRT and will be administered concurrently with EBRT, up to 5 days per week, for the 30-fraction course of EBRT for 6 weeks within 30±10 days post-surgery. After EBRT and concurrent TMZ phase, the first cycle begins 28 ±7 days following the last day of the EBRT and Concurrent TMZ Phase. Adjuvant TMZ includes 5 days of TMZ treatment at the start of each 28-day cycle. Additional cycles (up to a maximum of 12), which may be given at the discretion of the Investigator, will be documented, and performed in the same manner as done in the first 6 cycles. |
| Maximal safe resection + GammaTile followed by EBRT with concurrent TMZ then adjuvant TMZ (Arm B) | Experimental | Device: GammaTile®, Radiation: External Beam Radiation Therapy, Drug: TemozolomideAll patients will undergo tumor resection + GammaTile implantation. Start TMZ (75 mg/m2/day orally) on the first day of EBRT and will be administered concurrently with EBRT, up to 5 days per week, for the 20-fraction course of EBRT for 4 weeks within 30±10 days post-surgery. After EBRT and concurrent TMZ phase, the first cycle begins 28 ±7 days following the last day of the EBRT and Concurrent TMZ Phase. Adjuvant TMZ includes 5 days of TMZ treatment at the start of each 28-day cycle. Additional cycles (up to a maximum of 12), which may be given at the discretion of the Investigator, will be documented, and performed in the same manner as done in the first 6 cycles. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients must be ≥18 years of age.
- Have radiographic suspicion of newly diagnosed glioblastoma (GBM).
- o If final pathology reports IDH mutant glioma, then the patients found to have an IDH mutation will be followed for safety and QoL measures but will not be included in the primary and secondary comparative survival and efficacy analyses.
- Are medically and surgically appropriate for resection.
- Have an estimated Karnofsky Performance Scale (KPS) score of ≥70.
Key exclusion criteria (3 listed)
- A previous biopsy diagnosis other than IDH wild-type GBM.
- Have contraindications to TMZ, magnetic resonance imaging, gadolinium, or non-contrast computed tomography.
- Have multi-focal enhancing tumors that cannot be encompassed in one operative field.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GammaTile®GammaTiles are a U.S. FDA-cleared, surgically targeted radiation therapy for patients with certain brain tumors. GammaTile consists of bioresorbable collagen tiles embedded with Cesium-131 (Cs-131) radioactive seeds | Device | Maximal safe resection + GammaTile followed by EBRT with concurrent TMZ then adjuvant TMZ (Arm B) |
| External Beam Radiation TherapyAlso: EBRTExternal beam radiation therapy (EBRT) is a type of radiation therapy that is standard of care. EBRT uses a machine outside the body to deliver high-energy beams of radiation to cancerous areas within the body | Radiation | Maximal safe resection + GammaTile followed by EBRT with concurrent TMZ then adjuvant TMZ (Arm B), Maximal safe resection followed by EBRT with concurrent TMZ followed by adjuvant TMZ (Arm A) |
| TemozolomideAlso: TMZTMZ (Chemotherapy) is used as a first-line treatment, often in combination with radiation therapy after surgical resection of the tumor | Drug | Maximal safe resection + GammaTile followed by EBRT with concurrent TMZ then adjuvant TMZ (Arm B), Maximal safe resection followed by EBRT with concurrent TMZ followed by adjuvant TMZ (Arm A) |
Primary outcome
Overall Survival
Time frame: Days from surgery to death.
The primary endpoint of the study is OS, defined as the day from surgery to death. Patients who are still alive (or lost to follow-up) at the time of data analysis will be censored at the last time point they were known to be alive.
5 secondary outcomes
Progression Free Survival
Time frame: Days from surgery to death or disease progression.
Time to next unplanned treatment
Time frame: Time to next unplanned treatment.
Performance Status
Time frame: 24 months.
Safety Assessment
Time frame: Study duration.
Quality of Life Assessments
Time frame: COST-Score duration of study; FACT-Br up to 12 months after randomization.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing GammaTile®, External Beam Radiation Therapy and Temozolomide in people with Glioblastoma, run by GT Medical Technologies, Inc. at 13 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kimberly Johnson ((833)662-0044, kjohnson@gammatile.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (time frame: Days from surgery to death.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2026.