Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT07195591 · ClinicalTrials.gov registry record · Phase 3
Beginning Radiation Immediately With GammaTile at GBM Excision Versus Standard of Care
A Phase 3 study of Glioblastoma, sponsored by GT Medical Technologies.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 766
- Enrollment target
- 3
- Study locations
NCT07195591 is a Phase 3 study of Glioblastoma that is actively recruiting participants, run by GT Medical Technologies. The registered enrollment target is 766 participants, above the 105-participant average among 199 other Glioblastoma trials with a reported enrollment target (630% higher). The trial reports 3 study locations across 3 states.
The verdict
NCT07195591, a Phase 3 study of Glioblastoma, is actively recruiting participants, sponsored by GT Medical Technologies.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 766 participants
- Enrollment target
- 3
- Study locations
Study 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. * 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 Studied
Interventions
- RADIATION External Beam Radiation Therapy
- DRUG Temozolomide
- DEVICE GammaTile®
Study Locations (3)
New Jersey
- HMH Jersey Shore University Medical Center - Neptune City
New York
- Westchester Medical Center - Valhalla
Rhode Island
- Brown University Health - Providence
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 766 participants |
| Start Date | 2025-12-10 |
| Est. Completion | 2031-12 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07195591
The ClinicalTrials.gov registry entry for NCT07195591 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 766 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 105-participant average among 199 other Glioblastoma trials with a reported enrollment target (630% higher). The listed sponsor is GT Medical Technologies, which has 4 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Glioblastoma appearing as the primary indexed condition, and to 3 interventions - of which External Beam Radiation Therapy is the first listed.
NCT07195591 reports 3 study locations spanning 3 distinct geographic areas - top geographies include New Jersey, New York, Rhode Island.
Frequently Asked Questions
What is clinical trial NCT07195591 about?
NCT07195591 is a clinical study titled "Beginning Radiation Immediately With GammaTile at GBM Excision Versus Standard of Care". 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 patie...
What is the current status of trial NCT07195591?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 766 participants. The study started on 2025-12-10. Estimated completion is 2031-12.
What conditions does trial NCT07195591 study?
This clinical trial studies the following conditions: Glioblastoma.
What interventions are being tested in trial NCT07195591?
The interventions under investigation include: External Beam Radiation Therapy (RADIATION), Temozolomide (DRUG), GammaTile® (DEVICE).
Who is sponsoring clinical trial NCT07195591?
This trial is sponsored by GT Medical Technologies, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07195591 being conducted?
This trial has 3 study locations across New Jersey, New York, Rhode Island. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Glioblastoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
EF-41/KEYNOTE D58: Phase 3 Study of Optune Concomitant With Temozolomide Plus Pembrolizumab in Newly Diagnosed Glioblastoma
RECRUITING · Phase 3
-
A Study Comparing Niraparib With Temozolomide in Adult Participants With Newly-diagnosed, MGMT Unmethylated Glioblastoma
RECRUITING · Phase 3
-
Advanced Imaging Techniques for Evaluating the Tumor Immune Microenvironment in Glioblastoma Patients
RECRUITING · Phase 3
-
Repeated Superselective Intraarterial Cerebral Infusion (SIACI) of Bevacizumab With Temozolomide and Radiation Compared to Temozolomide and Radiation Alone in Newly Diagnosed GBM
RECRUITING · Phase 3
-
Intraoperative Radiotherapy in Newly Diagnosed Glioblastoma Multiforme
ACTIVE NOT RECRUITING · Phase 3
-
Tofacitinib in Recurrent GBM Patients
ACTIVE NOT RECRUITING · Phase 3
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.