Who is eligible for clinical trial NCT04002479?

Participants must meet protocol criteria for Pancreatic Cancer. Confirm exact inclusion and exclusion requirements with the study coordinator.

Does clinical trial NCT04002479 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2025-12-01

Alpha Radiation Emitters Device for the Treatment of Advanced Pancreatic Cancer (NCT04002479)

🔵 Active, Not Recruiting Observational / Diagnostic ⚙️ Medical Device Protocol Sponsor: Alpha Tau Medical LTD.

🩺 Plain-English Summary (8th-Grade Level)

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

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (9 items) and avoid the listed exclusions (12 items).

Location: Centre Hospitalier de l'Université de Montréal (CHUM) — Montreal, Quebec

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Histologically and/or cytologically proven locally advanced (Stage II or III) or metastatic (Stage IV) pancreatic, adenocarcinoma
Inoperable pancreatic cancer due to at least one of the following: a) unresectability, b) metastatic disease, c) medically unfit for surgery
ECOG performance status ≤ 2
Measurable lesion per RECIST (version 1.1) criteria
Maximum lesion of 4cm in the longest diameter (including primary tumor and regional lymph nodes)
≥ 18 years of age
Estimated life expectancy of at least 12 weeks
Women of childbearing potential (WOCBP) will have evidence of negative pregnancy test
Subjects are willing to sign an informed consent

Usually NOT eligible if any of the following apply:

Exclusion Criteria:
Prior chemotherapy does not exclude the patient
Prior abdominal radiation therapy
Concomitant chemotherapy or immunotherapy
Borderline resectable pancreatic cancer and medically fit for surgery
Connective tissue disease (scleroderma, lupus)
Patients with significant comorbidities that the treating physician deems may conflict with the endpoints of the study (e.g., poorly controlled autoimmune diseases, vasculitis, etc.)
Patients undergoing systemic immunosuppressive therapy excepting intermittent, brief use of systemic corticosteroids
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)
Patients not willing to sign an informed consent form
Women who are pregnant or lactating

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (2 Sites)

Centre Hospitalier de l'Université de Montréal (CHUM) — Montreal, Quebec
Jewish General Hospital — Montreal, Quebec

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

🏛️ View Official NIH Record ↗