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.
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
Chirurgia Generale e del Pancreas, Istituto del Pancreas
Verona, Italy
RECRUITINGFeasibility- DaRT seed placement
Feasibility will be determined according to the rate of successful placement of DaRT seeds via imaging
Time frame: Immediately following the insertion procedure
Safety- Adverse events, Safety will be determined according to the overall incidence of device-related SAE's graded according to CTCAE v5.0 criteria
Safety will be determined according to the overall incidence of device-related SAE's graded according to CTCAE v5.0 criteria
Time frame: from DaRT-insertion up to 48 hours
To evaluate the Efficacy of the Alpha DaRT seeds for locally advanced pancreatic cancer
Local control evaluation according to RECIST v1.1
Time frame: 1 months and 3 months
To evaluate the Efficacy of the Alpha DaRT seeds by measuring the CA-19-9 markers levels
Change in CA 19-9 levels
Time frame: 1 months and 3 months
Efficacy - to evaluate what is the percent of the Tumor Coverage by the Alpha DaRT seeds
Tumor Coverage
Time frame: immediately following the insertion procedure]
Efficacy- Alpha DaRT seeds
Overall incidence of device-related SAE's graded according to CTCAE v5.0 criteria
Time frame: from DaRT-insertion up to initiation of a possible postablation therapy or up to a maximum three months
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