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NCT05362409 · ClinicalTrials.gov registry record · Phase 1
Study to Evaluate 5-ALA Combined With CV01 Delivery of Ultrasound in Recurrent High Grade Glioma
A Phase 1 study of High Grade Glioma, sponsored by Alpheus Medical.
- Completed
- Registry status
- Phase 1
- Development phase
- 22
- Enrollment target
- 3
- Study locations
NCT05362409: Completed Phase 1 study of High Grade Glioma, sponsored by Alpheus Medical.
NCT05362409 is a Phase 1 study of High Grade Glioma that has completed, run by Alpheus Medical. The registered enrollment target is 22 participants, below the 65-participant average among 42 other High Grade Glioma trials with a reported enrollment target (66% lower). The trial reports 3 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05362409, a Phase 1 study of High Grade Glioma, has completed, sponsored by Alpheus Medical.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 22 participants
- Enrollment target
- 3
- Study locations
Study Summary
A Phase 1 Multi-center clinical Trial Evaluating the Safety and Tolerability of 5-aminolevulinic Acid (5-ALA) Combined With CV01 Delivery of Ultrasound for Sonodynamic Therapy (SDT) in Patients With recurrent High Grade Glioma (HGG).
Primary Outcome
Safety and tolerability as determined by the incidence of adverse events (AEs), including severe AEs and serious AEs (SAEs)
Conditions Studied
Interventions
- DRUG 5 Aminolevulinic Acid
- DEVICE CV01-delivered ultrasound
Study Locations (3)
New York
- Dent Neurosciences Research Center - Amherst
- Northwell - Lake Success
Missouri
- Washington University School of Medicine in St.Louis - St Louis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2022-06-29 |
| Est. Completion | 2025-02-03 |
| Phase | Phase 1 |
What the finished NCT05362409 record still lists
NCT05362409 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 22 participants, a relatively small participant target, below the 65-participant average among 42 other High Grade Glioma trials with a reported enrollment target (66% lower).
The record links to 1 condition, with High Grade Glioma appearing as the primary indexed condition, and to 2 interventions - of which 5 Aminolevulinic Acid is the first listed.
NCT05362409 reports a single indexed study location in New York, Missouri.
Frequently Asked Questions
What is clinical trial NCT05362409 about?
NCT05362409 is a clinical study titled "Study to Evaluate 5-ALA Combined With CV01 Delivery of Ultrasound in Recurrent High Grade Glioma". A Phase 1 Multi-center clinical Trial Evaluating the Safety and Tolerability of 5-aminolevulinic Acid (5-ALA) Combined With CV01 Delivery of Ultrasound for Sonodynamic Therapy (SDT) in Patients With recurrent High Grade Glioma (HGG).
What is the current status of trial NCT05362409?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 22 participants. The study started on 2022-06-29. Estimated completion is 2025-02-03.
What conditions does trial NCT05362409 study?
This clinical trial studies the following conditions: High Grade Glioma.
What interventions are being tested in trial NCT05362409?
The interventions under investigation include: 5 Aminolevulinic Acid (DRUG), CV01-delivered ultrasound (DEVICE).
Who is sponsoring clinical trial NCT05362409?
This trial is sponsored by Alpheus Medical, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05362409 being conducted?
This trial has 3 study locations across Missouri, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05362409's enrollment target sits among peer trials
22 30th of 42 higher than 13 of 42 other High Grade Glioma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other High Grade Glioma 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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