Testing an Ultrasound Device With a Study Drug for Newly Diagnosed Glioblastoma
Official title: Adjuvant Temozolomide ± 5-Aminolevulinic Acid + Low Intensity Diffuse Ultrasound Sonodynamic Therapy System for Newly Diagnosed Glioblastoma
Status: Recruiting. It is looking for patients now. Talk to your care team about whether it fits you.
The trial team last updated this record on .
The short version
This trial is testing whether a study drug plus a non-invasive ultrasound device can help people with newly diagnosed glioblastoma: The fastest-growing type of glioma (grade 4). Treatment usually starts soon after diagnosis: surgery first, then radiation and chemotherapy. See the glossary after their usual treatment.
Read our full plain-language summary
What the trial team says
The purpose of this research is to test an investigational device using ultrasound along with an investigational drug to see if it is useful in treating glioblastoma following standard of care therapy surgery and chemoradiation. This study is evaluating an experimental treatment for glioblastoma that uses an investigational drug (5-ALA) combined with a non-invasive ultrasound device (LIDU) to target tumor cells. Patients meeting the entry requirements to be in the study, will be equally randomly assigned to receive the study device plus the active study drug plus active ultrasound, or to a "sham" procedure where the ultrasound is not being activated and the study drug is a placebo (looks the same but does not contain active drug). Neither the patient or the investigator will know who is in the active group or not. Both groups will continue to receive the standard therapy of oral Temozolomide.
Key facts
- Registry number
- NCT07225621
- Stage of testing
- Phase 2
- Conditions studied
- Glioblastoma, GBM
Where it is running
This trial lists 11 sites.
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Massachusetts
- Dana Farber Cancer Institute (Boston)
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Minnesota
- Mayo Clinic (Rochester)
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New York
- Albany Medical Center (Albany)
- Dent Neurologic Institute (Buffalo)
- Northwell Health (Long Island City)
- New York Langone (New York)
- Columbia University (New York)
- Memorial Sloan Kettering Cancer Center (New York)
- University of Rochester (Rochester)
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Ohio
- Ohio State University (Columbus)
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Pennsylvania
- Penn State Milton S. Hershey Medical Center (Hershey)
How to use this
Talk to your care team first. They know your history and can tell you whether this trial is worth your time.
Joining a trial is always your choice. A trial is a test, not a proven treatment. Being in one is not a promise that it will help you.
This page is built from the trial's listing on ClinicalTrials.gov, a service of the U.S. National Library of Medicine. That listing is the authority, and it may have changed since we last read it. We do not run this trial and we cannot enroll you in it.