OncoMatch/Clinical Trials/NCT06039709
Sonodynamic Therapy in Patients With Recurrent GBM
Is NCT06039709 recruiting? Yes, currently enrolling (Jun 2026). This Phase 1 trial studies 5-ALA and Low-Intensity Focused Ultrasound (SDT) for recurrent glioblastoma.
Treatment: 5-ALA and Low-Intensity Focused Ultrasound (SDT) — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Glioblastoma
Performance status
KARNOFSKY 70–100
Demographics
Prior therapy
Cannot have received: sonodynamic therapy
Lab requirements
Blood counts
Absolute neutrophil count (ANC) ≥1000/mm3; Platelets ≥ 100,000/mm3; Hemoglobin ≥ 11 g/dL for women and ≥ 12 g/dL for men; INR ≤ 1.4
Kidney function
Creatinine clearance CrCl ≥ 60 mL/min/1.73 m2 as estimated by the Cockcroft-Gault (C-G) equation. If estimated CrCl is abnormal, accurate measurement should be obtained by 24-hour CrCl. Estimated glomerular filtration rate ≥30mL/min/1.73m2
Liver function
Bilirubin ≤ 1.5 x ULN (except in patients with Gilbert's disease, where bilirubin to 2.0x ULN is allowed); AST and ALT ≤ 3 x ULN; Alkaline phosphatase ≤ 3 x ULN
Has adequate bone marrow and organ function as defined by the following laboratory values (as assessed by the local laboratory for eligibility): Hematological: Absolute neutrophil count (ANC) ≥1000/mm3; Platelets ≥ 100,000/mm3; Hemoglobin ≥ 11 g/dL for women and ≥ 12 g/dL for men; INR ≤ 1.4. Renal & Hepatic: Creatinine clearance CrCl ≥ 60 mL/min/1.73 m2 as estimated by the Cockcroft-Gault (C-G) equation. If estimated CrCl is abnormal, accurate measurement should be obtained by 24-hour CrCl. Bilirubin ≤ 1.5 x ULN (except in patients with Gilbert's disease, where bilirubin to 2.0x ULN is allowed). AST and ALT ≤ 3 x ULN. Alkaline phosphatase ≤ 3 x ULN. Estimated glomerular filtration rate ≥30mL/min/1.73m2
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of Virginia · Charlottesville, Virginia
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT06039709 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior sonodynamic therapy disqualifies patients from enrollment.
Is there an age limit?
Yes. Patients must be 80 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages