A Study to Assess the Feasibility and Safety of Intratumoral Diffusing Alpha Emitters for the Treatment of Recurrent Glioblastoma
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.
Arms & interventions
- DeviceDevice :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
Outcome measures
Primary
Feasibility - DaRT seed placement
Feasibility will be determined according to the rate of successful placement of Alpha DaRT sources into brain tumors.
Time frame: 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
Time frame: From day 0 until 12 months
Secondary
Toxicity profile
Time frame: within 4 weeks of completion of postoperative radiotherapy
Radiographic local tumor control
Time frame: from 1 month following surgery and onwards
Rate of pseudo-progression at first post-implant scan
Time frame: 1 month following surgery
Overall survival
Time frame: up to 12 months post implant
Eligibility criteria
Study locations (3)
Honor Health
Scottsdale, Arizona, 85260
NYU Langone Health
New York, New York, 10016
Ohio State University Medical Center
Columbus, Ohio, 43210