A unique approach for cancer treatment employing intratumoral diffusing alpha radiation emitter device for the treatment of recurrent Glioblastoma
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
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
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
Honor Health
Scottsdale, Arizona, United States
RECRUITINGNYU Langone Health
New York, New York, United States
RECRUITINGOhio State University Medical Center
Columbus, Ohio, United States
RECRUITINGFeasibility - 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
Toxicity profile
according to CTCAE v5.0
Time frame: within 4 weeks of completion of postoperative radiotherapy
Radiographic local tumor control
per RANO criteria
Time frame: from 1 month following surgery and onwards
Rate of pseudo-progression at first post-implant scan
RANO criteria
Time frame: 1 month following surgery
Overall survival
Time frame: up to 12 months post implant
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.