NCT06910306

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Alpha Tau Medical LTD. · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Recurrent Glioblastoma
• Recurrent Gliomas

Interventions

Type	Name	Description
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

Timeline

• Start date: 2025-10-01
• Primary completion: 2026-11-01
• Completion: 2026-12-01
• First posted: 2025-04-04
• Last updated: 2026-04-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study