DaRT Device for Recurrent Glioblastoma
This study is testing a new device called DaRT seeds for people with recurrent glioblastoma (a type of brain cancer) or recurrent gliomas. The DaRT seeds use alpha radiation (a type of energy) to treat the tumor. You might be able to join if you are between 18 and 85 years old and have a glioblastoma that has come back and is 3cm or smaller, and surgery isn't an option. The main goals are to see if the DaRT seeds can be safely placed and how well they work over 12 months. This study is looking for 10 participants.
- Study design
- This is an open-label, single-arm study involving 10 participants. It is designed to evaluate the feasibility and safety of the DaRT seeds.
- What's involved
- If you join, you will have DaRT seeds inserted. You will then have follow-up visits every two months for up to 12 months.
- Compensation
- Not stated in the trial record.
- Follow-up
- After the 12-month visits, survival follow-up will be done via phone calls every 2-3 months until new anti-cancer treatment, disease progression, or death.
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NCT06910306
Alpha Radiation Emitters Device (DaRT) for the Treatment of Recurrent Glioblastoma
Recruiting
NAAges 18–85InterventionalTreatmentAlpha Tau Medical LTD.
~10 participants
Updated 2026-07-21 on ClinicalTrials.gov
What's tested:Device :DaRT seeds
At a glance
Recruiting sites
3 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Feasibility - DaRT seed placement
Measured over From day 0 until 12 months
+1 more outcome measured
Conditions
Where it's being run
3 sites across 3 statesArizona1
New York1
Ohio1
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Males and females ≥ 18 and ≤ 85 years of age
Patients must have histologically confirmed diagnosis of WHO grade IV glioblastoma (including variants such as gliosarcoma, giant cell glioblastoma).
Single, gadolinium-enhancing tumor recurrence ≤ 3cm in maximum diameter
Patient not amenable for surgical resection due to any of the following but not limited reasons: patient refusal, medically ineligible, surgically too high risk due to tumor location in a deep and/or eloquent location.
Prior history of central nervous system (CNS) radiation (standard dose) with 50.4-60 Gy delivered in 1.8 Gy-2.0 Gy fractions with concurrent temozolomide (if the patient has received a non-standard fractionation or radiation dose, such as 40 Gy in 15 fractions.
Patients must have a time interval ≥4 months between completion of prior radiation and trial registration and have tumor progression per RANO criteria
Patients must have a measurable disease per RANO criteria
Estimated life expectancy is more than 6 months
Target lesion amenable for coverage by the DaRT sources
Patient must either have had recent subtotal surgery/biopsy following tumor recurrence (at least 6 weeks from trial registration) or must have shown unequivocal radiographic evidence for tumor progression by contrast-enhanced MRI scan within 21 days prior to trial registration. If surgery was performed, must have a post-operative MRI scan within 21 days prior to trial registration.
Patients have recovered from prior therapy side effects and must be at least 4 weeks post administration of chemotherapies or investigational agents with the exception of nitrosureas (such as Carmustine, Fotemustine, Lomustine) which requires 42 days of washout.
Karnofsky performance score (KPS) of at least 60 documented within 14 days prior to trial registration
Patients must have adequate biological parameters as demonstrated by the following blood counts at initial screening obtained ≤ 14 days prior to starting treatment Absolute neutrophil count (ANC) ≥ 1.5 × 109/L Platelet count ≥ 100,000/mm3 (80 × 109/L) Hemoglobin (Hgb) ≥ 9 g/dL.
Patients must have the following blood chemistry levels at initial screening obtained ≤ 14 days prior to starting treatment AST (SGOT), ALT (SGPT) ≤ 2.5 × upper limit of normal range (ULN) Total bilirubin ≤ 1.5 × ULN
Effective contraception must be used by both male and female patients while on the study and for up to 3 months following treatment
Patient must have been informed about the nature of the study, and must have agreed to participate in the study, and signed the Informed Consent Form (ICF) prior to participation in any study-related activities
Exclusion
Medical contraindication to MRI (cardiac devices are allowed if MRI compatible)
More than 3 relapses per RANO criteria
Acquired and or genetic clinical bleeding tendency
Suspicious of infratentorial or leptomeningeal or intraventricular disease
Concomitant chemotherapy or any other systemic therapy not allowed in the protocol
Recent or current (within 6 weeks) therapy with VEF or a VEGFR inhibitor
Immunocompromised state due to either transplant or AIDS
Prior allergic reaction to the study drugs
History of hypertensive crisis or hypertensive encephalopathy
Uncontrolled hypertension (defined as either \>150 mm/Hg for systolic and \>90mm/Hg for diastolic)
History of a non-healing wound, ulcer, gastrointestinal bleed (\> grade 3), traumatic injury, or bone fracture within 90 days prior to registration Volunteers participating in another interventional study in the past 30 days which might conflict with the endpoints of this study or the evaluation of response or toxicity of DaRT
High probability of protocol non-compliance (in opinion of investigator)
Pregnancy or lactation
Collagenous diseases, specifically systemic lupus erythematosus, scleroderma, or dermatomyositis
What this trial measures
- Feasibility - DaRT seed placementFrom day 0 until 12 months
Feasibility will be determined according to the rate of successful placement of Alpha DaRT sources into brain tumors.
- Safety - Adverse eventsFrom day 0 until 12 months
Safety will be determined according to incidence of acute grade 3 or greater unanticipated Adverse Events (AE) according to CTCAE v5.0 criteria