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NCT07225621 · ClinicalTrials.gov registry record · Phase 2
Adjuvant Temozolomide ± 5-Aminolevulinic Acid + Low Intensity Diffuse Ultrasound Sonodynamic Therapy System for Newly Diagnosed Glioblastoma
A Phase 2 study of Glioblastoma and GBM, sponsored by Alpheus Medical.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 103
- Enrollment target
- 8
- Study locations
NCT07225621: Recruiting Phase 2 study of Glioblastoma and GBM, sponsored by Alpheus Medical.
NCT07225621 is a Phase 2 study of Glioblastoma and GBM that is actively recruiting participants, run by Alpheus Medical. The registered enrollment target is 103 participants, roughly in line with the 108-participant average among 199 other Glioblastoma trials with a reported enrollment target. The trial reports 8 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07225621, a Phase 2 study of Glioblastoma and GBM, is actively recruiting participants, sponsored by Alpheus Medical.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 103 participants
- Enrollment target
- 8
- Study locations
Study Summary
The purpose of this research is to test an investigational device using ultrasound along with an investigational drug to see if it is useful in treating glioblastoma following standard of care therapy surgery and chemoradiation. This study is evaluating an experimental treatment for glioblastoma that uses an investigational drug (5-ALA) combined with a non-invasive ultrasound device (LIDU) to target tumor cells. Patients meeting the entry requirements to be in the study, will be equally randomly assigned to receive the study device plus the active study drug plus active ultrasound, or to a "sham" procedure where the ultrasound is not being activated and the study drug is a placebo (looks the same but does not contain active drug). Neither the patient or the investigator will know who is in the active group or not. Both groups will continue to receive the standard therapy of oral Temozolomide.
Conditions Studied
Interventions
- COMBINATION_PRODUCT 5-ALA HCl + LIDU SDT
- COMBINATION_PRODUCT Placebo + Sham SDT
Study Locations (8)
New York
- Albany Medical Center - Albany
- Dent Neurologic Institute - Buffalo
- Northwell Health - Long Island City
- New York Langone - New York
- Columbia University - New York
Massachusetts
- Dana Farber Cancer Institute - Boston
North Carolina
- University of North Carolina - Chapel Hill
Pennsylvania
- Penn State Milton S. Hershey Medical Center - Hershey
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 103 participants |
| Start Date | 2026-01-28 |
| Est. Completion | 2028-12 |
| Phase | Phase 2 |
What NCT07225621 shows while recruiting
NCT07225621 is an interventional study that assigns participants to a tested intervention. The registered 103 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 108-participant average among 199 other Glioblastoma trials with a reported enrollment target.
The record links to 2 conditions, with Glioblastoma appearing as the primary indexed condition, and to 2 interventions - of which 5-ALA HCl + LIDU SDT is the first listed.
NCT07225621 lists 8 locations in 4 states (New York, Massachusetts, North Carolina).
Frequently Asked Questions
What is clinical trial NCT07225621 about?
NCT07225621 is a clinical study titled "Adjuvant Temozolomide ± 5-Aminolevulinic Acid + Low Intensity Diffuse Ultrasound Sonodynamic Therapy System for Newly Diagnosed Glioblastoma". The purpose of this research is to test an investigational device using ultrasound along with an investigational drug to see if it is useful in treating glioblastoma following standard of care therapy surgery and chemoradiation. This study is evaluating an experimental treatment for glioblastoma tha...
What is the current status of trial NCT07225621?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 103 participants. The study started on 2026-01-28. Estimated completion is 2028-12.
What conditions does trial NCT07225621 study?
This clinical trial studies the following conditions: Glioblastoma, GBM.
What interventions are being tested in trial NCT07225621?
The interventions under investigation include: 5-ALA HCl + LIDU SDT (COMBINATION_PRODUCT), Placebo + Sham SDT (COMBINATION_PRODUCT).
Who is sponsoring clinical trial NCT07225621?
This trial is sponsored by Alpheus Medical, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07225621 being conducted?
This trial has 8 study locations across Massachusetts, New York, North Carolina, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT07225621's enrollment target sits among peer trials
103 44th of 199 higher than 156 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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