Adjuvant Temozolomide ± 5-Aminolevulinic Acid + Low Intensity Diffuse Ultrasound Sonodynamic Therapy System for Newly Diagnosed Glioblastoma (NCT07225621)
Multi-Center, Randomized, Double-Blind, Placebo-Controlled Trial Comparing Standard of Care Adjuvant Temozolomide With or Without 5-Aminolevulinic Acid (5-ALA) With Concomitant Low Intensity Diffuse Ultrasound (LIDU) Sonodynamic Therapy (SDT) System In Patients With Newly Diagnosed Glioblastoma After Completion of Chemoradiotherapy
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Dana Farber Cancer Institute — Boston, Massachusetts
Age range: 18 Years to 80 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (11 Sites)
- Dana Farber Cancer Institute — Boston, Massachusetts
- Mayo Clinic — Rochester, Minnesota
- Albany Medical Center — Albany, New York
- Dent Neurologic Institute — Buffalo, New York
- Northwell Health — Long Island City, New York
- New York Langone — New York, New York
- Columbia University — New York, New York
- Memorial Sloan Kettering Cancer Center — New York, New York
- University of Rochester — Rochester, New York
- Ohio State University — Columbus, Ohio
- Penn State Milton S. Hershey Medical Center — Hershey, Pennsylvania
📞 Contact the Study Coordinator
Phone: (484) 252-1960
Email: AMHulstine@alpheusmedical.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Glioblastoma
- Analyzing Pulsed Reduced Dose Radiotherapy in Upfront Glioblastoma — Milwaukee, Wisconsin
- A Dose Finding Study of [177Lu]Lu-DOTA-TATE in Newly Diagnosed Glioblastoma in Combination With Standard of Care and in Recurrent Glioblastoma as a Single Agent. — New York, New York
- A Phase 1-2 Study of ST101 in Patients With Advanced Solid Tumors — San Francisco, California
- Trial of Niraparib in Participants With Newly-diagnosed Glioblastoma and Recurrent Glioma — Phoenix, Arizona
- A Study Comparing Niraparib With Temozolomide in Adult Participants With Newly-diagnosed, MGMT Unmethylated Glioblastoma — Birmingham, Alabama
- Testing the Addition of the Chemotherapy Drug Lomustine (Gleostine) to the Usual Treatment (Temozolomide and Radiation Therapy) for Newly Diagnosed MGMT Methylated Glioblastoma — Fairbanks, Alaska
Explore by condition: All Glioblastoma clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.