Actively Recruiting
Alpha Radiation Emitters Device (DaRT) for the Treatment of Recurrent Glioblastoma
Led by Alpha Tau Medical LTD. · Updated on 2026-04-06
10
Participants Needed
1
Research Sites
60 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
A unique approach for cancer treatment employing intratumoral diffusing alpha radiation emitter device for the treatment of recurrent Glioblastoma
CONDITIONS
Official Title
Alpha Radiation Emitters Device (DaRT) for the Treatment of Recurrent Glioblastoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Males and females aged 18 to 85 years
- Histologically confirmed diagnosis of WHO grade IV glioblastoma, including gliosarcoma and giant cell glioblastoma
- Single recurrent tumor with gadolinium enhancement measuring 3 cm or less in maximum diameter
- Not suitable for surgical removal due to medical reasons, patient refusal, or tumor location
- Prior standard central nervous system radiation of 50.4-60 Gy with concurrent temozolomide
- At least 4 months since prior radiation completion with tumor progression per RANO criteria
- Measurable disease according to RANO criteria
- Estimated life expectancy longer than 6 months
- Tumor accessible for coverage by DaRT sources
- Recent subtotal surgery or biopsy at least 6 weeks before registration, or clear tumor progression on MRI within 21 days prior to registration
- Recovery from prior therapies with minimum 4 weeks since chemotherapy or investigational agents (42 days for nitrosureas)
- Karnofsky performance score of at least 60 within 14 days before registration
- Adequate blood counts and chemistry within 14 days before treatment start
- Use of effective contraception during study and for 3 months after treatment
- Informed consent signed prior to participation
You will not qualify if you...
- Contraindication to MRI (except MRI-compatible cardiac devices)
- More than 3 tumor relapses per RANO criteria
- Known bleeding disorders or genetic bleeding tendencies
- Suspicion of infratentorial, leptomeningeal, or intraventricular disease
- Concurrent chemotherapy or systemic therapy not allowed by the protocol
- Recent or current therapy with VEGF or VEGFR inhibitors within 6 weeks
- Immunocompromised state due to transplant or AIDS
- Prior allergic reaction to study drugs
- History of hypertensive crisis or encephalopathy
- Uncontrolled hypertension (systolic >150 mmHg or diastolic >90 mmHg)
- Recent serious wounds, ulcers, gastrointestinal bleeding, injuries, or bone fractures within 90 days
- Participation in another interventional study in past 30 days that conflicts with this study
- High risk of not complying with the study protocol
- Pregnancy or breastfeeding
- Collagen diseases such as lupus, scleroderma, or dermatomyositis
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Ohio State University Medical Center
Columbus, Ohio, United States, 43210
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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