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NCT05342883 · ClinicalTrials.gov registry record · Phase 4
GammaTile and Stupp in Newly Diagnosed GBM
A Phase 4 study of Glioblastoma, sponsored by GT Medical Technologies.
- Active
- Registry status
- Phase 4
- Development phase
- 61
- Enrollment target
- 16
- Study locations
NCT05342883: Active Phase 4 study of Glioblastoma, sponsored by GT Medical Technologies.
NCT05342883 is a Phase 4 study of Glioblastoma that is active but no longer recruiting, run by GT Medical Technologies. The registered enrollment target is 61 participants, below the 109-participant average among 199 other Glioblastoma trials with a reported enrollment target (44% lower). The trial reports 16 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05342883, a Phase 4 study of Glioblastoma, is active but no longer recruiting, sponsored by GT Medical Technologies.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 4
- Development phase
- 61 participants
- Enrollment target
- 16
- Study locations
Study Summary
In summary, standard of care postoperative chemoradiation for patients with newly diagnosed GBM does not routinely provide durable local control or prolonged overall survival. As discussed above it seems unlikely that patient outcomes will be significantly improved with radiation dose escalation given at the time of the EBRT boost. However, as most failures are local, improving LC could potentially improve the OS of patients. To do this, we propose a shift in the traditional radiation paradigm. This study will assess the feasibility and tolerability of adding GT radiation therapy as an upfront boost at the time of maximum safe resection, along with the backbone of the current standard of care approach, concomitant and adjuvant temozolomide +/- TTF, for patients with newly diagnosed GBM. GT, a novel brain brachytherapy device utilizing Cs-131 embedded in bioresorbable collagen tiles, offers a more sophisticated carrier and a shorter half-life radioisotope, Cs-131. Use of this device allows for radiation initiation at an earlier time point and a more rapid dose delivery and possibly more effective tumor control particularly for rapidly proliferating tumors such as GBM. Two prospective studies have demonstrated the safety and efficacy of re-irradiation with GT in patients with recurrent GBM. The overarching goal of this single-arm, open label phase 4 study is to determine the feasibility and tolerability of treating patients with GammaTile in combination with the Stupp Protocol and how to proceed with testing this treatment in a future, larger, randomized clinical study. The aims of the study are to demonstrate that the use of GammaTile at the time of surgery is well tolerated and does not delay the start of the Stupp protocol. Efficacy outcomes (e.g., LC, OS, PFS) will also be described.
Primary Outcome
Feasibility of using GammaTiles in patients who will also be treated with the Stupp Protocol.
Conditions Studied
Interventions
- DEVICE Surgical tumor resection, GammaTile radiation therapy implantation, Stupp protocol (EBRT and Temozolamide)
Study Locations (16)
California
- Keck Medicine of USC - Los Angeles
- UC Davis Comprehensive Cancer Center - Sacramento
Florida
- Advent Health Orlando - Orlando
- Florida Health Sciences Center, Inc. d/b/a Tampa General Hospital - Tampa
Arizona
- HonorHeath Scottsdale Osborn Medical Center - Scottsdale
Georgia
- Piedmont Healthcare - Atlanta
Illinois
- RUSH University - Chicago
Indiana
- Indiana University Office of Clinical Research - Indianapolis
Kansas
- University of Kansas Hospital - Kansas City
Michigan
- Henry Ford Health System - Detroit
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 61 participants |
| Start Date | 2022-08-17 |
| Est. Completion | 2027-12-01 |
| Phase | Phase 4 |
What the registry record for NCT05342883 still lists
NCT05342883 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 61 participants, a relatively small participant target, below the 109-participant average among 199 other Glioblastoma trials with a reported enrollment target (44% lower).
The record links to 1 condition, with Glioblastoma appearing as the primary indexed condition, and to 1 intervention - of which Surgical tumor resection, GammaTile radiation therapy implantation, Stupp protocol (EBRT and Temozolamide) is the first listed.
NCT05342883 lists 16 locations in 14 states (California, Florida, Arizona).
Frequently Asked Questions
What is clinical trial NCT05342883 about?
NCT05342883 is a clinical study titled "GammaTile and Stupp in Newly Diagnosed GBM". In summary, standard of care postoperative chemoradiation for patients with newly diagnosed GBM does not routinely provide durable local control or prolonged overall survival. As discussed above it seems unlikely that patient outcomes will be significantly improved with radiation dose escalation giv...
What is the current status of trial NCT05342883?
This trial is currently active not recruiting. It is a Phase 4 study. The enrollment target is 61 participants. The study started on 2022-08-17. Estimated completion is 2027-12-01.
What conditions does trial NCT05342883 study?
This clinical trial studies the following conditions: Glioblastoma.
What interventions are being tested in trial NCT05342883?
The interventions under investigation include: Surgical tumor resection, GammaTile radiation therapy implantation, Stupp protocol (EBRT and Temozolamide) (DEVICE).
Who is sponsoring clinical trial NCT05342883?
This trial is sponsored by GT Medical Technologies, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05342883 being conducted?
This trial has 16 study locations across Arizona, California, Florida, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05342883's enrollment target sits among peer trials
61 74th of 199 higher than 126 of 199 other Glioblastoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Glioblastoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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