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RECRUITINGNA

A Study to Assess the Feasibility and Safety of Intratumoral Diffusing Alpha Emitters for the Treatment of Recurrent Glioblastoma

NCT06910306•Alpha Tau Medical LTD.

Summary

A unique approach for cancer treatment employing intratumoral diffusing alpha radiation emitter device for the treatment of recurrent Glioblastoma

Detailed Description

This is a Prospective Open label Single arm Multi-center interventional study. The study is designed to evaluate the Feasibility and Safety of DaRT seeds for the treatment of recurrent Glioblastoma. A total of 10 subjects will be enrolled. Eligible patients who meet inclusion/exclusion criteria (as assessed during the screening period) will be invited to the site for the procedure of DaRT seeds insertion and will return for a follow up visit every 2 months (+/- 7 days ) up to 12 months (4 ,6 , 8, 10 and 12 ). Survival F.U (after visit 11) will be done via phone calls every 2-3 months until (1) the start of new anti-cancer treatment, (2) disease progression or (3) death, whichever occurs first.

Eligibility

Age

18 - 85 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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.
+6 more criteria

Exclusion Criteria

•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)
+4 more criteria

Locations (1)

Ohio State University Medical Center

Columbus, Ohio, United States

Key Dates

Start Date

October 1, 2025

Primary Completion Date

November 1, 2026

Completion Date

December 1, 2026

Last Updated

December 5, 2025

Enrollment

ESTIMATED participants

Conditions

Recurrent GlioblastomaRecurrent Gliomas

Interventions

Device :DaRT seeds

DEVICE

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 5, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study to Assess the Feasibility and Safety of Intratumoral Diffusing Alpha Emitters for the Treatment of Recurrent Glioblastoma

Inclusion Criteria

Exclusion Criteria

Testing the Addition of an Anti-Cancer Drug, Triapine, to the Usual Radiation Therapy for Recurrent Glioblastoma or Astrocytoma

Hypofractionation Trial of Re-irradiation in Good Prognosis Recurrent Glioblastoma

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