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Sonodynamic Therapy in Patients With Recurrent GBM

NCT06039709 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2026-04-28

No results posted yet for this study

Summary

Patients diagnosed with glioblastoma (GBM) are faced with limited treatment options. This pilot study will evaluate the safety and feasibility of combining an investigational drug called 5-ALA with neuronavigation-guided low-intensity focused ultrasound (LIFU) for patients who have recurrent GBM. Focused ultrasound (FUS) can be used to non-invasively destroy tumor tissue while preserving normal tissue. When FUS is combined with 5-ALA, this combinatorial approach is called sonodynamic therapy (SDT), and this investigational therapy is being tested for its ability to cause damage to GBM cells. SDT will take place prior to surgery for recurrent GBM.

Conditions

Interventions

COMBINATION_PRODUCT

5-ALA and Low-Intensity Focused Ultrasound (SDT)

5-ALA (20mg/kg orally) given \~6 hours prior to LIFU. Focused ultrasound will target a maximum of 50% of the tumor.

Sponsors & Collaborators

  • Shayan Moosa, MD

    lead OTHER

Principal Investigators

  • Shayan Moosa, MD · UVA

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-31
Primary Completion
2026-12-31
Completion
2027-06-30
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 NCT06039709 on ClinicalTrials.gov