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)
Nader Sanai
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 range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 lesi…
Interventions
- Combination ProductSONALA-001(ALA) and MR-Guided Focused Ultrasound device (MRgFUS)
SONALA-001(ALA) given 5-7 hours prior to receiving the MRgFUS.
- DeviceMR-Guided Focused Ultrasound device (MRgFUS)
MR-Guided Focused Ultrasound device (MRgFUS) alone
Location
- St. Joseph's Hospital and Medical CenterPhoenix, Arizona