Overview

Sonodynamic Therapy With SONALA-001 and Magnetic Resonance Guided Focused Ultrasound for the Treatment of Progressive or Recurrent Glioblastoma

Status:
RECRUITING

Trial end date:
2026-12-31

Target enrollment:

Participant gender:

Summary

This phase Ib trial tests the safety, best dose, and effectiveness of SONALA-001 in combination with magnetic resonance imaging-guided focused ultrasound (MRgFUS), also called sonodynamic therapy, in treating patients with glioblastoma that is growing, spreading, or getting worse (progressive) or that has come back after a period of improvement (recurrent). Sonodynamic therapy is a non-invasive combination therapy that uses low-intensity ultrasound, such as MRgFUS, to activate a drug, such as SONALA-001, to kill tumor cells. SONALA-001 binds to the tumor and may help the sonodynamic therapy target the tumor. MRgFUS is an image-guided, non-invasive technique that uses high energy ultrasound from the Exablate 4000 Type 2.0 device to kill tumors without damaging surrounding healthy tissue. Giving sonodynamic therapy using SONALA-001 with MRgFUS may be safe, tolerable, and/or effective in treating patients with progressive or recurrent glioblastoma.

Phase:

PHASE1

Details

Lead Sponsor:

Mayo Clinic

Collaborator:

National Cancer Institute (NCI)

Treatments:

Magnetic Resonance Spectroscopy
Specimen Handling