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Study to Evaluate 5-ALA Combined With CV01 Delivery of Ultrasound in Recurrent High Grade Glioma

NCT05362409 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2025-06-19

No results posted yet for this study

Summary

A Phase 1 Multi-center clinical Trial Evaluating the Safety and Tolerability of 5-aminolevulinic Acid (5-ALA) Combined With CV01 Delivery of Ultrasound for Sonodynamic Therapy (SDT) in Patients With recurrent High Grade Glioma (HGG).

Conditions

Interventions

DRUG

5 Aminolevulinic Acid

5-aminolevulinic acid \[5-ALA\] administered orally 20 mg/kg every 4 weeks

DEVICE

CV01-delivered ultrasound

CV01-delivered ultrasound every 4 weeks

Sponsors & Collaborators

  • Alpheus Medical, Inc.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-29
Primary Completion
2024-12-03
Completion
2025-02-03
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 NCT05362409 on ClinicalTrials.gov