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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 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.

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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.

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

FieldValue
Enrollment Target 8 participants
Start Date 2025-08-14
Est. Completion 2026-12-31
Phase Early Phase 1

Sponsor

Mayo Clinic

2,844 total trials

What the Registry Record Tells You About NCT07076472

The ClinicalTrials.gov registry entry for NCT07076472 describes a study currently listed as recruiting, categorized as Early Phase 1. The registered enrollment target is 8 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 69-participant average among 62 other Recurrent Glioblastoma trials with a reported enrollment target (88% lower). The listed sponsor is Mayo Clinic, which has 2,844 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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