A unique approach for cancer treatment employing intratumoral diffusing alpha radiation emitter device for advanced pancreatic cancer
This is a Prospective, interventional, open label, single arm, multiple center study. The study is designed to evaluate the feasibility and safety of the 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- 8 weeks and a long-term follow up phase of 3 months. The total duration of the study will be 3 months from the DaRT insertion procedure. 15 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 3 months post insertion
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
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
Wolfson Medical Center
Holon, Israel
NOT_YET_RECRUITINGHadassah Ein Kerem
Jerusalem, Israel
RECRUITINGFeasibility - DaRT seed placement
Feasibility will be determined according to the rate of successful placement of DaRT seeds via imaging
Time frame: From Day 0
Safety - Adverse events
Safety will be determined according to the overall incidence of device related SAE's graded according to CTCAE v5.0 criteria
Time frame: up to 3 months
Efficacy -Alpha DaRT seeds
The secondary objective of the study is to evaluate the efficacy of the Alpha DaRT seeds for advanced pancreatic cancer patients with respect to quality of life and tumor size.
Time frame: 1 month and 3 months]
Efficacy-Alpha DaRT seeds
Change in CA19-9 levels
Time frame: 1 month and 3 months
Efficacy-Alpha DaRT seeds
Tumor Coverage
Time frame: immediately following the insertion procedure
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