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RECRUITINGEARLY_PHASE1

Study of Sonodynamic Therapy in Participants with Recurrent High-Grade Glioma

A Phase 0, First in Human, Open-label Study of Intravenous Aminolevulinic Acid HCl (ALA) and MR-Guided Focused Ultrasound Device (MRgFUS) in Participants with Recurrent High Grade Glioma (HGG)

NCT04559685•Nader Sanai

View on ClinicalTrials.gov

Summary

A Phase 0 single center, first in human, open-label study of ascending energy doses of sonodynamic therapy (SDT) utilizing the MRgFUS combined with intravenous ALA to assess safety and efficacy in up to 45 participants with recurrent HGG. Eligible participants who are scheduled for resection will be administered intravenous (IV) aminolevulinic acid HCl (ALA) approximately six to seven (6-7) hours prior to receiving sonodynamic therapy (SDT).

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Arms A-D: Prior resection of histologically diagnosed high-grade gliomas (III and IV) defined as participants who have progressed on or following standard therapy as determined by the investigator. Arm E: Participant at first recurrence with an unmethylated HGG, has completed standard therapy and is not currently scheduled for resection.
•2. Recurrence must be confirmed by diagnostic biopsy with local pathology review or contrast-enhanced MRI with positive perfusion.
•3. Arms A-D (only): Have measurable disease preoperatively, defined as at least 1 contrast-enhancing lesion, with a volume of at least 6 cm3 and ≤ 20cm3 of targeted treatment area.
•4. Age ≥18 at time of consent.
•5. Have a performance status (PS) of ≤2 on the Eastern Cooperative Oncology (Group (ECOG) scale (Oken et al. 1982).
•6. Has adequate bone marrow and organ function as defined by the following laboratory values (as assessed by the local laboratory for eligibility)
•Adequate bone marrow function:
•* absolute neutrophil count ≥1,000/mcL
•* Platelets (at time of surgery) ≥100,000/mcL
•* hemoglobin ≥8.0 g/dL Participants may receive erythrocyte transfusions to achieve this hemoglobin level at the discretion of the investigator.
+14 more criteria

Exclusion Criteria

•1. Known active systemic bacterial infection (requiring intravenous \[IV\] antibiotics at time of initiating study treatment), fungal infection, or detectable viral infection (such as known human immunodeficiency virus positivity or with known active hepatitis B or C \[for example, hepatitis B surface antigen positive\]. Screening is not required for enrollment.
•2. Have had a recent (≤3 months prior to first dose of study drug) transient ischemic attack or stroke.
•3. Significant vascular disease (e.g. aortic aneurysm)
•4. Evidence of bleeding diathesis or coagulopathy
•5. Diagnosis of porphyria
•6. Unstable angina and/or congestive heart failure within the last 6 months
•7. Transmural myocardial infarction within the last 6 months
•8. Serious and inadequately controlled cardiac arrhythmia
•9. Acute exacerbation of chronic obstructive pulmonary disease
•10. Inability to undergo MRI (e.g., presence of a pacemaker)
+6 more criteria

Locations (1)

St. Joseph's Hospital and Medical Center

Phoenix, Arizona, United States

Key Dates

Start Date

March 15, 2021

Primary Completion Date

March 1, 2026

Completion Date

March 31, 2028

Last Updated

March 14, 2025

Enrollment

ESTIMATED participants

Conditions

High Grade Glioma

Interventions

SONALA-001(ALA) and MR-Guided Focused Ultrasound device (MRgFUS)

COMBINATION_PRODUCT

MR-Guided Focused Ultrasound device (MRgFUS)

DEVICE

Contacts

Phase 0 Navigator

CONTACT

602-406-8605 research@ivybraintumorcenter.org

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 14, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Study of Sonodynamic Therapy in Participants with Recurrent High-Grade Glioma

Inclusion Criteria

Exclusion Criteria

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