Actively Recruiting
Randomized Trial of Temozolomide With or Without 5-Aminolevulinic Acid and Low Intensity Diffuse Ultrasound Sonodynamic Therapy for Newly Diagnosed Glioblastoma
Led by Alpheus Medical, Inc. · Updated on 2026-06-05
103
Participants Needed
9
Research Sites
52 weeks
Total Duration
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AI-Summary
What this Trial Is About
Researchers are evaluating a new treatment approach for patients with newly diagnosed glioblastoma who have completed standard therapy including surgery and chemoradiation. This experimental treatment combines an investigational drug, 5-aminolevulinic acid (5-ALA), with a non-invasive low intensity diffuse ultrasound (LIDU) device to target tumor cells. The study aims to compare this combination plus standard oral temozolomide chemotherapy to a placebo plus a sham ultrasound procedure, assessing the impact on patient outcomes. Participants will be randomly assigned to one of two groups: one receiving the active investigational drug and ultrasound treatment along with temozolomide, and the other receiving a placebo drug and a sham ultrasound procedure plus temozolomide. The investigational oral drug is taken 6 to 8 hours before the ultrasound therapy, which lasts about 40 minutes. Both groups start temozolomide treatment shortly after the ultrasound or sham procedure, following the approved dosing schedule. During the study, participants will be monitored for progression-free survival up to 24 months, as well as overall survival and treatment-related side effects. Evaluations will include clinical assessments and safety monitoring throughout the trial. Participants will continue receiving standard care and will be followed regularly to assess treatment effects and any adverse events. The total duration of observation and outcome measurement is up to two years.
CONDITIONS
Brief Title
Adjuvant Temozolomide ± 5-Aminolevulinic Acid + Low Intensity Diffuse Ultrasound Sonodynamic Therapy System for Newly Diagnosed Glioblastoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient must provide informed consent and agree to follow study requirements
- Aged 18 to 80 years
- WHO performance status of 2 or less at screening
- Newly diagnosed glioblastoma confirmed by biopsy without IDH mutation
- No disease progression after surgery and chemoradiation with temozolomide
- Completed radiotherapy with at least 90% of planned dose and chemotherapy with over 66% of planned doses
- Any side effects from chemoradiation resolved to baseline or Grade 2 or less (except hair loss or low lymphocytes)
- Adequate bone marrow and organ function based on lab tests
- Adequate blood clotting function
- Women must be non-pregnant, non-lactating and use contraception if of childbearing potential
- Negative pregnancy test within 7 days before first 5-ALA dose for women of childbearing potential
- Men must be surgically sterile or use effective contraception during study and 30 days after
- No other anti-cancer treatments after radiation except temozolomide per protocol
You will not qualify if you...
- Tumors located in the cerebellum or brainstem
- Tumors affecting both brain hemispheres or involving brainstem or cerebellum
- Multiple tumor areas not contiguous or too large for ultrasound treatment
- Leptomeningeal disease
- Gliosarcoma diagnosis
- Planned use of tumor treating fields during study
- Use of corticosteroids above 4 mg/day dexamethasone or equivalent
- Unable to have MRI with contrast
- Allergies to 5-ALA or related compounds
- Head size too large to fit device helmet
- Large skull defects or implants incompatible with device
- Recent stroke or brain bleeding within 6 months unrelated to surgery
- History of glioma or other cancers within 3 years unless successfully treated
- Severe brain swelling needing urgent treatment
- Rapid health decline expected to worsen during treatment
- Prior glioma treatments other than surgery and chemoradiation
- Porphyria or gastrointestinal issues affecting absorption
- Active hepatitis B, C, or HIV infection
- Participation in another interventional glioblastoma trial
- Inability to avoid certain phototoxic drugs around 5-ALA dosing
- Other serious medical conditions that interfere with study participation
- Women who are pregnant or breastfeeding
- Inability to provide informed consent or comply with study procedures
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 24 months
Participants receive oral 5-ALA HCl or placebo followed by low intensity diffuse ultrasound sonodynamic therapy or sham therapy, combined with standard of care temozolomide chemotherapy.
Regular visits for treatment as per standard of care chemotherapy schedule
Duration - Up to 24 months
Participants are monitored for progression-free survival, overall survival, and treatment-related adverse events after treatment.
Periodic visits up to 24 months post-treatment
Trial Site Locations
Total: 9 locations
1
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
2
Albany Medical Center
Albany, New York, United States, 12208
Actively Recruiting
3
Dent Neurologic Institute
Buffalo, New York, United States, 14226
Actively Recruiting
4
Northwell Health
Long Island City, New York, United States, 11030
Actively Recruiting
5
New York Langone
New York, New York, United States, 10016
Actively Recruiting
6
Columbia University
New York, New York, United States, 10032
Actively Recruiting
7
University of Rochester
Rochester, New York, United States, 19642
Actively Recruiting
8
Ohio State University
Columbus, Ohio, United States, 43210
Actively Recruiting
9
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
Actively Recruiting
Research Team
A
Ann-Marie VP, Clinical Operations
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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