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

NCT06910306 | Recruiting FDA Device

• 1 other identifier: CTP-GBM-01
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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

Keywords

Recurrent Glioblastoma; Brachytherapy; GBM; Alpha DaRT sources; Intratumoral Diffusing Alpha Emitters

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Toxicity profile

  within 4 weeks of completion of postoperative radiotherapy

• Radiographic local tumor control

  from 1 month following surgery and onwards

• Rate of pseudo-progression at first post-implant scan

  1 month following surgery

• Overall survival

  up to 12 months post implant

Study Arms (1)

Experimental: DaRT seeds

EXPERIMENTAL

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

Interventions

Device :DaRT seeds DEVICE

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

Experimental: DaRT seeds

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Alpha Tau Medical LTD.: lead

Study Sites (1)

Ohio State University Medical Center

Columbus, Ohio, 43210, United States

RECRUITING

MeSH Terms

Conditions

Glioblastoma; Glioma

Condition Hierarchy (Ancestors)

Astrocytoma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a prospective , Multicenter , Open label, Single arm with DaRT for the treatment of Recurrent Glioblstoma .

Study Record Dates

• First Submitted: September 23, 2024
• First Posted: April 4, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: December 5, 2025

Record last verified: 2025-09

Locations

US (1)