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

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

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

Study Overview

• Status: Recruiting
• Conditions: Recurrent Glioblastoma; Recurrent Gliomas
• Intervention / Treatment: Device: Device :DaRT seeds

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.

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Recruiting
      • Ohio State University Medical Center
      • Contact: Joshua Palmer, MD; Phone Number: 917-601-3414; Email: joshua.palmer@osumc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 .	Device: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility - DaRT seed placement	Feasibility will be determined according to the rate of successful placement of Alpha DaRT sources into brain tumors.	From day 0 until 12 months
Safety - Adverse events	Safety will be determined according to incidence of acute grade 3 or greater unanticipated Adverse Events (AE) according to CTCAE v5.0 criteria	From day 0 until 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Toxicity profile	according to CTCAE v5.0	within 4 weeks of completion of postoperative radiotherapy
Radiographic local tumor control	per RANO criteria	from 1 month following surgery and onwards
Rate of pseudo-progression at first post-implant scan	RANO criteria	1 month following surgery
Overall survival		up to 12 months post implant

Collaborators and Investigators

• Sponsor: Alpha Tau Medical LTD.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: September 23, 2024
• First Submitted That Met QC Criteria: April 2, 2025
• First Posted (Actual): April 4, 2025

Study Record Updates

• Last Update Posted (Actual): April 6, 2026
• Last Update Submitted That Met QC Criteria: March 31, 2026
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: GBM; Recurrent Glioblastoma; Brachytherapy; Alpha DaRT sources; Intratumoral Diffusing Alpha Emitters
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Astrocytoma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Glioblastoma; Glioma
• Other Study ID Numbers: CTP-GBM-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes