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

Not Applicable

Recruiting

• Conditions: Metastatic Pancreatic Cancer; Pancreatic Adenocarcinoma; Pancreatic Cancer; Unresectable Pancreatic Cancer

• Registration Number: NCT05657743
• Lead Sponsor: Alpha Tau Medical LTD.

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, 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 Timeline

• Study First Submitted: 2022-11-21
• Study First Submitted QC: 2022-12-11
• Study First Posted: 2022-12-20
• Study Start: 2023-08-16
• Status Verified: 2025-01
• Last Update Submitted: 2025-02-06
• Last Update Posted: 2025-02-07
• Primary Completion: 2025-11
• Study Completion: 2025-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

Not provided

Exclusion Criteria

• 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.
• Patients undergoing systemic immunosuppressive therapy excepting intermittent, brief use of systemic corticosteroids.
• Clinically significant cardiovascular disease, e.g. cardiac failure of New York Heart Association classes III-IV, uncontrolled coronary artery disease, cardiomyopathy, uncontrolled arrhythmia, uncontrolled hypertension, or history of myocardial infarction in the last 12 months.
• Patients with uncontrolled intercurrent illnesses including, but not limited to an active infection requiring systemic therapy or a known psychiatric or substance abuse disorder(s) that would interfere with cooperation with the requirements of the trial or interfere with the study endpoints.
• Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer.
• Patient requires treatment not specified in this protocol which may conflict with the endpoints of this study including evaluation of response or toxicity of DaRT.
• Patients do not agree to use adequate contraception (vasectomy or barrier method of birth control) prior to study entry, for the duration of study participation and for 3 months after discontinuing therapy.
• Volunteers participating in another interventional study in the past 30 days which might conflict with the endpoints of this study or the evaluation of response or toxicity of DaRT.
• High probability of protocol non-compliance (in opinion of investigator).
• Breastfeeding women or women of childbearing potential unwilling or unable to use an acceptable contraceptive method to prevent pregnancy for 3 months after RT.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Feasibility - DaRT seed placement	From Day 0	Feasibility will be determined according to the rate of successful placement of DaRT seeds via imaging
Safety - Adverse events	up to 3 months	Safety will be determined according to the overall incidence of device related SAE's graded according to CTCAE v5.0 criteria

Secondary Outcome Measures

Name	Time	Method
Efficacy -Alpha DaRT seeds	1 month and 3 months]	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	immediately following the insertion procedure	Tumor Coverage

Trial Locations

Locations (2)

Wolfson Medical Center; 🇮🇱 H̱olon, Israel

Hadassah Ein Kerem; 🇮🇱 Jerusalem, Israel