Actively Recruiting
A Study to Assess the Feasibility and Safety of Intratumoral Diffusing Alpha Emitters for the Treatment of Recurrent Glioblastoma
Led by Alpha Tau Medical LTD. · Updated on 2026-04-06
10
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a unique cancer treatment using a device that emits alpha radiation directly into tumors to treat recurrent glioblastoma, a type of aggressive brain tumor. This open-label, single-arm study aims to assess how feasible and safe it is to use DaRT seeds implanted inside the tumor for this condition. The study will enroll 10 participants with recurrent glioblastoma who meet specific criteria. Participants will undergo a procedure where DaRT seeds containing Ra-224 are inserted into their tumor using a special applicator according to a planned approach. After the procedure, they will return for follow-up visits every two months for up to 12 months. Survival will also be monitored by phone every 2 to 3 months until the start of new cancer treatment, disease progression, or death. During the study, researchers will evaluate the placement of the DaRT seeds and monitor adverse events related to the treatment over 12 months. They will also assess tumor control through imaging, toxicity after radiotherapy, pseudo-progression rates, and overall survival. Participants will have various assessments including MRI scans and clinical evaluations at scheduled visits. The study involves continuous safety monitoring throughout the treatment and follow-up period.
CONDITIONS
Brief Title
Alpha Radiation Emitters Device (DaRT) for the Treatment of Recurrent Glioblastoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 to 85 years
- Histologically confirmed diagnosis of WHO grade IV glioblastoma, including variants
- Single tumor recurrence 3 cm or less in maximum diameter
- Not suitable for surgical resection due to refusal, medical ineligibility, or high surgical risk
- Prior standard CNS radiation with 50.4-60 Gy in 1.8-2.0 Gy fractions with temozolomide
- At least 4 months since completion of prior radiation and tumor progression per RANO criteria
- Measurable disease per RANO criteria
- Estimated life expectancy over 6 months
- Tumor lesion suitable for DaRT source coverage
- Recent subtotal surgery or biopsy at least 6 weeks prior, or recent MRI showing tumor progression within 21 days
- Recovery from prior treatments with at least 4 weeks washout from chemotherapy except 42 days for nitrosureas
- Karnofsky performance score of at least 60 within 14 days prior to registration
- Adequate blood counts and chemistry within 14 days prior to treatment start
- Use of effective contraception during study and for 3 months after
- Signed informed consent prior to study participation
You will not qualify if you...
- Contraindication to MRI (except MRI-compatible cardiac devices)
- More than 3 tumor relapses per RANO criteria
- Bleeding disorders, acquired or genetic
- Suspicion of infratentorial, leptomeningeal, or intraventricular disease
- Use of chemotherapy or systemic therapy not allowed by protocol
- Recent or current therapy with VEGF or VEGFR inhibitors within 6 weeks
- Immunocompromised state from transplant or AIDS
- Prior allergic reaction to study drugs
- History of hypertensive crisis or encephalopathy
- Uncontrolled hypertension (systolic >150 mmHg or diastolic >90 mmHg)
- Non-healing wound, ulcer, severe gastrointestinal bleed, traumatic injury, or bone fracture within 90 days
- Participation in another interventional study within 30 days that conflicts with this study
- High risk of non-compliance as judged by investigator
- Pregnancy or breastfeeding
- Collagenous diseases such as lupus, scleroderma, or dermatomyositis
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 - Day 0
Participants undergo the procedure to have DaRT seeds inserted into their tumor using a designated Alpha DaRT Applicator.
1 procedure visit (in-person)
Duration - Up to 12 months
Participants return for follow-up visits every 2 months to monitor safety, feasibility, and tumor response after DaRT seed insertion.
Follow-up visits every 2 months (in-person) at months 2, 4, 6, 8, 10, and 12
Duration - Variable after 12 months
Participants are contacted by phone every 2 to 3 months to check survival status until new anti-cancer treatment starts, disease progression, or death.
Phone calls every 2 to 3 months
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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