A unique approach for cancer treatment employing intratumoral diffusing alpha radiation emitter device for advanced pancreatic cancer
Histologically and/or cytologically proven locally advanced or metastatic pancreatic adenocarcinoma
Patients must have i) received at least one line of chemotherapy OR ii) are medically unfit for further chemotherapy, AND iii) the tumor is still not deemed as resectable with radical surgery or the patient does not wish to go through surgery
Target lesion is technically amenable for at least 50% coverage by the Alpha DaRT seeds as determined by the treating physician
Interstitial radiation indication validated by a multidisciplinary team
Concomitant chemotherapy or immunotherapy within the past 4 weeks
Brain metastases
Borderline unresectable pancreatic cancer, and/or cases fit for surgical exploration unless patient refuses surgery
Known hypersensitivity to any of the components of the treatment.
Single group
Radiation: Diffusing Alpha Radiation Emitters Therapy (DaRT)
DeviceAn 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
Feasibility - DaRT seed placement
Feasibility will be determined according to the rate of successful placement of DaRT seeds via imaging
Safety - Adverse events
Safety will be determined according to the overall incidence of device related SAE's graded according to CTCAE v5.0 criteria
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.
Efficacy-Alpha DaRT seeds
Change in CA19-9 levels
Efficacy-Alpha DaRT seeds
Tumor Coverage
Exploratory objective-Blood samples will be collected for immune response biomarker analyses. Blood samples will be analyzed using FACS and change to the following immune biomarkers will be assessed: CD3, CD4, CD8, CD69, CD137
• Changes in immune markers following treatment with the Alpha DaRT seeds for the treatment of advanced pancreatic cancer. o CD3 * CD4 * CD8 * CD69 * CD137
Exploratory objective
Tumor response using EUS
Blood radioactivity measurements
Exploratory Objective-Blood samples will be collected and shipped using a designated sample collection kit provided by the Sponsor. The vials will be sent to a central vendor per the instruction provided in the associated laboratory manual.
Urine radioactivity measurements
Urine samples will be collected and shipped using a designated sample collection kit provided by the Sponsor . the vials will be sent to central vendor per the instruction provided in the associated laboratory manual
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