Sonodynamic Therapy in Patients With Recurrent GBM

Part of paid clinical trials in Charlottesville, Virginia.

Sponsor
Shayan Moosa, MD
Study ID
NCT06039709
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • 5-ALA and Low-Intensity Focused Ultrasound (SDT) — COMBINATION_PRODUCT
    5-ALA (20mg/kg orally) given \~6 hours prior to LIFU. Focused ultrasound will target a maximum of 50% of the tumor.

Study Details

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.

Key Dates

Start date
Jan 31, 2024
Status verified
Apr 2026
Primary completion
Dec 31, 2026
Completion
Jun 30, 2027

Study Design

Enrollment
11 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Sonodynamic Therapy (5-ALA + LIFU)
    Administration of SDT occurs 1-3 weeks prior to GBM resection

Primary Outcome Measure

Incidence of adverse events [ Time Frame: From informed consent through 30 days after study intervention is complete ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of VirginiaCharlottesvilleVirginia22903
Zachary Sturgill
[email protected]
4342439986
Judith Beenhakker, MS
[email protected]
4349821856
Shayan Moosa, MD (PRINCIPAL_INVESTIGATOR)
Joseph Donahue, MD (SUB_INVESTIGATOR)

Find similar trials in Charlottesville, VA

By condition
Brain cancer
By specialty
OncologyNeuro-oncology
By research site
University of Virginia· Charlottesville, VA

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