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A Feasibility and Safety Study of Intratumoral Diffusing Alpha Radiation Emitters on Advanced Pancreatic Cancer
A unique approach for cancer treatment employing intratumoral diffusing alpha radiation emitter device for advanced pancreatic cancer.
This is a prospective, single-center, open label, single arm study. The study is designed to evaluate the feasibility, safety and preliminary efficacy of intratumoral alpha radiation mediated treatment with Alpha DaRT seeds for the treatment of advanced pancreatic cancer. The study will be comprised of a screening period, DaRT insertion visit, acute follow-up phase of 4-6 weeks and a long-term follow up phase of 24 months. The total duration of the study will be 24 months from the DaRT insertion procedure. 30 patients with advanced pancreatic cancer will be recruited by the investigational site. 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. The patients will be monitored for a period of 24 months post insertion.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Centre Hospitalier de l'Université de Montréal (CHUM)
Montreal, Quebec, Canada
Jewish General Hospital
Montreal, Quebec, Canada
Start Date
October 20, 2020
Primary Completion Date
October 1, 2026
Completion Date
October 1, 2026
Last Updated
December 2, 2025
37
ESTIMATED participants
Radiation: Diffusing Alpha Radiation Emitters Therapy (DaRT)
DEVICE
Lead Sponsor
Alpha Tau Medical LTD.
NCT05053971
NCT04550494
Data Source & Attribution
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