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NCT04559685 · ClinicalTrials.gov registry record · Early Phase 1
Study of Sonodynamic Therapy in Participants with Recurrent High-Grade Glioma
A Early Phase 1 study of High Grade Glioma, sponsored by Nader Sanai.
- Recruiting
- Registry status
- Early Phase 1
- Development phase
- 30
- Enrollment target
- 1
- Study location
NCT04559685: Recruiting Early Phase 1 study of High Grade Glioma, sponsored by Nader Sanai.
NCT04559685 is a Early Phase 1 study of High Grade Glioma that is actively recruiting participants, run by Nader Sanai. The registered enrollment target is 30 participants, below the 65-participant average among 42 other High Grade Glioma trials with a reported enrollment target (54% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04559685, a Early Phase 1 study of High Grade Glioma, is actively recruiting participants, sponsored by Nader Sanai.
- RECRUITING
- Registry status
- Early Phase 1
- Development phase
- 30 participants
- Enrollment target
- 1
- Study location
Study Summary
A Phase 0 single center, first in human, open-label study of ascending energy doses of sonodynamic therapy (SDT) utilizing the MRgFUS combined with intravenous ALA to assess safety and efficacy in up to 45 participants with recurrent HGG. Eligible participants who are scheduled for resection will be administered intravenous (IV) aminolevulinic acid HCl (ALA) approximately six to seven (6-7) hours prior to receiving sonodynamic therapy (SDT).
Primary Outcome
The percentage (%) of Cleaved Caspase-3 of the surgical tissue will be quantified and compared to intra-patient control specimens.
Conditions Studied
Interventions
- COMBINATION_PRODUCT SONALA-001(ALA) and MR-Guided Focused Ultrasound device (MRgFUS)
- DEVICE MR-Guided Focused Ultrasound device (MRgFUS)
Study Locations (1)
Arizona
- St. Joseph's Hospital and Medical Center - Phoenix
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2021-03-15 |
| Est. Completion | 2028-03-31 |
| Phase | Early Phase 1 |
What NCT04559685 shows while recruiting
NCT04559685 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 65-participant average among 42 other High Grade Glioma trials with a reported enrollment target (54% lower).
The record links to 1 condition, with High Grade Glioma appearing as the primary indexed condition, and to 2 interventions - of which SONALA-001(ALA) and MR-Guided Focused Ultrasound device (MRgFUS) is the first listed.
NCT04559685 reports a single indexed study location in Arizona.
Frequently Asked Questions
What is clinical trial NCT04559685 about?
NCT04559685 is a clinical study titled "Study of Sonodynamic Therapy in Participants with Recurrent High-Grade Glioma". A Phase 0 single center, first in human, open-label study of ascending energy doses of sonodynamic therapy (SDT) utilizing the MRgFUS combined with intravenous ALA to assess safety and efficacy in up to 45 participants with recurrent HGG. Eligible participants who are scheduled for resection will be...
What is the current status of trial NCT04559685?
This trial is currently recruiting. It is a Early Phase 1 study. The enrollment target is 30 participants. The study started on 2021-03-15. Estimated completion is 2028-03-31.
What conditions does trial NCT04559685 study?
This clinical trial studies the following conditions: High Grade Glioma.
What interventions are being tested in trial NCT04559685?
The interventions under investigation include: SONALA-001(ALA) and MR-Guided Focused Ultrasound device (MRgFUS) (COMBINATION_PRODUCT), MR-Guided Focused Ultrasound device (MRgFUS) (DEVICE).
Who is sponsoring clinical trial NCT04559685?
This trial is sponsored by Nader Sanai, which has 13 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04559685 being conducted?
This trial has 1 study location across Arizona. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04559685's enrollment target sits among peer trials
30 24th of 42 higher than 18 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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