Recruiting

Intratumoral Diffusing Alpha RadiationAlpha Radiation Emitters Device (DaRT) for the Treatment of Recurrent Glioblastoma

Sponsor:

Alpha Tau Medical LTD.

Code:

NCT06910306

Conditions

Recurrent Glioblastoma

Recurrent Gliomas

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Device :DaRT seeds

Study Details

Brief summary:

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

Conditions

Recurrent Glioblastoma

Recurrent Gliomas

Study ID

NCT06910306

Start date

Oct 1, 2025

Status verified date

Sep, 2025

Completion date

Dec 1, 2026

Anticipated

Primary completion date

Nov 1, 2026

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.
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 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)
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

Study Design

Enrollment

10 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Experimental: DaRT seeds

DaRT sources are inserted into the tumor according to a pre determined plan. The delivery of the DaRT Sources into the tumor is done by using a designated Alpha DaRT Applicator .

Interventions

Device :DaRT seeds

The sources are impregnated with a layer containing Ra-224 which is well fixated to the surface of the source. Ra-224 undergoes a series of decay events with each daughter product producing an alpha particle

Primary outcome measure

Feasibility - DaRT seed placement [ Time Frame: From day 0 until 12 months ]
Safety - Adverse events [ Time Frame: From day 0 until 12 months ]

Central Contacts and Locations

Locations

Honor Health

Recruiting

Scottsdale, Arizona, United States, 85260

Contacts

John Wanebo, MD

480-583-0192 john.wanebo@barrowbrainandspine.com

Claudia Crroks, MS

480-583-0192 ccrooks@honorhealth.com

NYU Langone Health

Recruiting

New York, New York, United States, 10016

Contacts

Daniel Orringer, MD

734-709-2196 daniel.orringer@nyulangone.org

Teresa Russell

212-263-5035 Teresa.Russell@nyulangone.org

Ohio State University Medical Center

Recruiting

Columbus, Ohio, United States, 43210

Contacts

Joshua Palmer, MD

917-601-3414 joshua.palmer@osumc.edu

More Information

Sponsor

Alpha Tau Medical LTD.

Last update posted

Jul 21, 2026

Last verified

Sep, 2025

Keywords

Recurrent Glioblastoma
Brachytherapy
GBM
Alpha DaRT sources
Intratumoral Diffusing Alpha Emitters

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Alpha Tau Medical LTD. on 2026-07-21.