drugset / Trial / NCT04559685
Study of Sonodynamic Therapy in Participants With Recurrent High-Grade Glioma
Phase 0
Terminated
10 enrolled
Nader Sanai
Barrow Neurological Institute · collabInSightec · collabIvy Brain Tumor Center · collabSonALAsense, Inc. · collab
Non-randomizedSequentialOpen-labelTreatment
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).
Timeline
- Start
- 2021-03-15
- Primary completion
- 2023-08-23
- Completion
- 2024-11-10
Outcome
Outcome not reported
Stopped: “Study terminated due to unavailability of the investigational product required to continue the study.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | SONALA-001 | Unknown | — | Intravenous |