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Intratumoral Diffusing alpha-emitters Radiation Therapy (DaRT) Seeds

An intratumoral insertion of radioactive sources \[Ra-224 containing stainless-steel 316LVM tubes- (Alpha DaRT seeds)\]. The seeds release by recoil into the tumor short-lived alpha-emitting atoms

DaRT seeds insertion

Liron Dimnik

Salvatore Paiella, MD

A unique approach for cancer treatment employing intratumoral diffusing alpha radiation emitter device for advanced pancreatic cancer

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.

Alpha Radiation Emitters Device for the Treatment of Pancreatic Cancer Emitters for the Treatment of Locally Advanced Pancreatic Cancer

A Feasibility and Safety Study of Intratumoral Diffusing Alpha Radiation Emitters for the Treatment of Locally Advanced Pancreatic Cancer

Changes in immune markers following treatment ,These biomarkers include:

* CD3
* CD4
* CD8
* CD69
* CD137

Feasibility will be determined according to the rate of successful placement of DaRT seeds via imaging

Safety will be determined according to the overall incidence of device-related SAE's graded according to CTCAE v5.0 criteria

Local control evaluation according to RECIST v1.1

Overall incidence of device-related SAE's graded according to CTCAE v5.0 criteria

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Alpha Radiation Emitters Device for the Treatment of Pancreatic Cancer Emitters for the Treatment of Locally Advanced Pancreatic Cancer	NCT06026943	Pancreatic Canc... Unresectable Pa... Pancreatic Aden...	DaRT seeds inse...	18 Years - 120 Years	Alpha Tau Medical LTD.
Alpha Radiation Emitters Device for the Treatment of Pancreatic Cancer Emitters for the Treatment of Locally Advanced Pancreatic Cancer	NCT06026943	Pancreatic Canc... Unresectable Pa... Pancreatic Aden...	DaRT seeds inse...	18 Years - 120 Years	Alpha Tau Medical LTD.

Spots Global Cancer Trial Database for dart seeds insertion