MedTrace Logo

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

NCT04559685 · Status: TERMINATED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2026-05-14

No results posted yet for this 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).

Conditions

Interventions

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

Sponsors & Collaborators

  • Barrow Neurological Institute

    collaborator OTHER

  • Ivy Brain Tumor Center

    collaborator OTHER

  • SonALAsense, Inc.

    collaborator INDUSTRY

  • InSightec

    collaborator INDUSTRY

  • Nader Sanai

    lead OTHER

Principal Investigators

  • Nader Sanai, MD · St. Joseph's Hospital and Medical Center, Phoenix

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-15
Primary Completion
2023-08-23
Completion
2024-11-10
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04559685 on ClinicalTrials.gov