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Brief Title: Alpha Radiation Emitters Device for the Treatment of Pancreatic Cancer Emitters for the Treatment of Locally Advanced Pancreatic Cancer
Official Title: A Feasibility and Safety Study of Intratumoral Diffusing Alpha Radiation Emitters for the Treatment of Locally Advanced Pancreatic Cancer
Study ID: NCT06026943
Brief Summary: A unique approach for cancer treatment employing intratumoral diffusing alpha radiation emitter device for advanced pancreatic cancer
Detailed Description: This is a prospective, interventional, single-center, open label, single arm study. The study is designed to evaluate the feasibility and Safety of Intratumoral Diffusing Alpha Radiation Emitters for the Treatment of Locally Advanced Pancreatic Cancer The study will be comprised of a screening period, DaRT insertion visit, 3 months follow up per subject and 2 years for accrual and trial completion. The total duration of the study will be 24 months from the DaRT insertion procedure. 15 patients with a safety interim analysis after the 5 first patients . 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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Name: Salvatore Paiella, MD
Affiliation: Pancreas Institute - Integrated University Hospital of Verona
Role: PRINCIPAL_INVESTIGATOR