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NCT07076472 · ClinicalTrials.gov registry record · Early Phase 1
Sonodynamic Therapy With SONALA-001 or 5-ALA HCL and Magnetic Resonance Guided Focused Ultrasound for the Treatment of Progressive or Recurrent Glioblastoma
A Early Phase 1 study of Recurrent Glioblastoma and Progressive Glioblastoma, sponsored by Mayo Clinic.
- Recruiting
- Registry status
- Early Phase 1
- Development phase
- 8
- Enrollment target
- 1
- Study location
NCT07076472: Recruiting Early Phase 1 study of Recurrent Glioblastoma and Progressive Glioblastoma, sponsored by Mayo Clinic.
NCT07076472 is a Early Phase 1 study of Recurrent Glioblastoma and Progressive Glioblastoma that is actively recruiting participants, run by Mayo Clinic. The registered enrollment target is 8 participants, below the 69-participant average among 62 other Recurrent Glioblastoma trials with a reported enrollment target (88% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07076472, a Early Phase 1 study of Recurrent Glioblastoma and Progressive Glioblastoma, is actively recruiting participants, sponsored by Mayo Clinic.
- RECRUITING
- Registry status
- Early Phase 1
- Development phase
- 8 participants
- Enrollment target
- 1
- Study location
Study Summary
This early phase I trial tests the safety, best dose, and effectiveness of SONALA-001 or 5-ALA HCL in combination with magnetic resonance imaging-guided focused ultrasound (MRgFUS), also called sonodynamic therapy, in treating patients with glioblastoma that is growing, spreading, or getting worse (progressive) or that has come back after a period of improvement (recurrent). Sonodynamic therapy is a non-invasive combination therapy that uses low-intensity ultrasound, such as MRgFUS, to activate a drug, such as SONALA-001 or 5-ALA HCL, to kill tumor cells. SONALA-001 or 5-ALA HCL binds to the tumor and may help the sonodynamic therapy target the tumor. MRgFUS is an image-guided, non-invasive technique that uses high energy ultrasound from the Exablate 4000 Type 2.0 device to kill tumors without damaging surrounding healthy tissue. Giving sonodynamic therapy using SONALA-001 or 5-ALA HCL with MRgFUS may be safe, tolerable, and/or effective in treating patients with progressive or recurrent glioblastoma.
Primary Outcome
Defined per the Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5 as AEs considered to be at least possibly related to study treatment. The maximum grade for each type of AE will be recorded for each patient, and frequency tables will be reviewed to determine patterns (by dose level and overall).
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Computed Tomography
- PROCEDURE Magnetic Resonance Imaging
- OTHER Electronic Health Record Review
- DRUG Aminolevulinic Acid Intravenous Formulation SONALA-001
Study Locations (1)
Minnesota
- Mayo Clinic in Rochester - Rochester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2025-08-14 |
| Est. Completion | 2026-12-31 |
| Phase | Early Phase 1 |
What NCT07076472 shows while recruiting
NCT07076472 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 69-participant average among 62 other Recurrent Glioblastoma trials with a reported enrollment target (88% lower).
The record links to 2 conditions, with Recurrent Glioblastoma appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT07076472 reports a single indexed study location in Minnesota.
Frequently Asked Questions
What is clinical trial NCT07076472 about?
NCT07076472 is a clinical study titled "Sonodynamic Therapy With SONALA-001 or 5-ALA HCL and Magnetic Resonance Guided Focused Ultrasound for the Treatment of Progressive or Recurrent Glioblastoma". This early phase I trial tests the safety, best dose, and effectiveness of SONALA-001 or 5-ALA HCL in combination with magnetic resonance imaging-guided focused ultrasound (MRgFUS), also called sonodynamic therapy, in treating patients with glioblastoma that is growing, spreading, or getting worse (...
What is the current status of trial NCT07076472?
This trial is currently recruiting. It is a Early Phase 1 study. The enrollment target is 8 participants. The study started on 2025-08-14. Estimated completion is 2026-12-31.
What conditions does trial NCT07076472 study?
This clinical trial studies the following conditions: Recurrent Glioblastoma, Progressive Glioblastoma.
What interventions are being tested in trial NCT07076472?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Magnetic Resonance Imaging (PROCEDURE), Electronic Health Record Review (OTHER), Aminolevulinic Acid Intravenous Formulation SONALA-001 (DRUG).
Who is sponsoring clinical trial NCT07076472?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07076472 being conducted?
This trial has 1 study location across Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Recurrent Glioblastoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT07076472's enrollment target sits among peer trials
8 60th of 62 higher than 2 of 62 other Recurrent Glioblastoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Recurrent Glioblastoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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