NCT04559685

Study of Sonodynamic Therapy in Participants with Recurrent High-Grade Glioma

A Phase 0, First in Human, Open-label Study of Intravenous Aminolevulinic Acid HCl (ALA) and MR-Guided Focused Ultrasound Device (MRgFUS) in Participants with Recurrent High Grade Glioma (HGG)

• Status: Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Nader Sanai · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• High Grade Glioma

Interventions

Type	Name	Description
COMBINATION_PRODUCT	SONALA-001(ALA) and MR-Guided Focused Ultrasound device (MRgFUS)	SONALA-001(ALA) given 5-7 hours prior to receiving the MRgFUS.
DEVICE	MR-Guided Focused Ultrasound device (MRgFUS)	MR-Guided Focused Ultrasound device (MRgFUS) alone

Timeline

• Start date: 2021-03-15
• Primary completion: 2026-03-01
• Completion: 2028-03-31
• First posted: 2020-09-23
• Last updated: 2025-03-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study