Sonodynamic Therapy With SONALA-001 or 5-ALA HCL and Magnetic Resonance Guided Focused Ultrasound for the Treatment of Progressive or Recurrent Glioblastoma
Sponsor: Mayo Clinic • ClinicalTrials.gov ID: NCT07076472
Recruiting for Similar Conditions?
Sponsors are looking for patients like you. See if you qualify for compensated research studies.
Check Eligibility →Description
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
-
Aminolevulinic Acid Intravenous Formulation SONALA-001
(Drug)
Given IV
-
Biospecimen Collection
(Procedure)
Undergo blood sample collection
-
Computed Tomography
(Procedure)
Undergo CT
-
Electronic Health Record Review
(Other)
Ancillary studies
-
Magnetic Resonance Imaging
(Procedure)
Undergo MRI
-
MRI-Guided Focused Ultrasound Ablation
(Procedure)
Undergo transcranial MRgFUS
-
Oral Aminolevulinic Acid Hydrochloride
(Drug)
Given PO
Eligibility criteria
Conditions
Locations
- Mayo Clinic in Rochester — Rochester, Minnesota, United States
Partner with Nurenyx
Showcase your study to thousands of motivated patients matching your criteria.
Learn MoreOfficial Source
Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
View Official Record