Alpha Radiation Emitters Device for the Treatment of Advanced Pancreatic Cancer

NCT04002479 | Active Not Recruiting

• 1 other identifier: AT-PANC-101
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Pancreatic Cancer; Unresectable Pancreatic Cancer; Metastatic Pancreatic Cancer; Pancreatic Adenocarcinoma

Keywords

pancreatic cancer; Unresectable Pancreatic Cancer; Metastatic Pancreatic Cancer; Pancreatic Adenocarcinoma; Pancreas Neoplasm; Alpha radiation; Pancreas Cancer; Pancreas Metastases

Outcome Measures

Primary Outcomes (3)

• Feasibility - DaRT seed placement

  Assessment of the DaRT seed placement within the tumor or less than 5 mm from the tumor using CT imaging on the day of DaRT insertion.

  Day 0 (Day of insertion)

• Safety - Adverse events

  Assessment of the frequency, severity and causality of acute AEs and SAEs related to DaRT seeds insertion. AEs and SAEs will be assessed and graded according to Common Terminology and Criteria for Adverse Events (CTCAE) version 5.0

  3 months

• Safety - Adverse events

  Assessment of the frequency, severity and causality of Late AEs and SAEs related to DaRT seeds insertion. AEs and SAEs will be assessed and graded according to Common Terminology and Criteria for Adverse Events (CTCAE) version 5.0. The follow up will be carried out by phone calls every 2 months during the time between 3 to 24 months after DaRT seeds insertion

  3 to 24 months

Secondary Outcomes (6)

• Efficiency - Short-term effect

  4-6 weeks after DaRT seeds insertion

• Tissue damage evaluation

  Day -14 to 60 days after insertion

• Efficiency - Long-term effect

  2 years following DaRT seeds insertion

• Stent durability

  Day of DaRT insertion up to 24 months.

• Change in quality of life: EORTC-QLQ-C30

  Day -14 to 60 days after insertion

Study Arms (1)

DaRT Seeds

EXPERIMENTAL

Intratumoral Diffusing alpha-emitters Radiation Therapy (DaRT) Seeds

Device: Radiation: Diffusing Alpha Radiation Emitters Therapy (DaRT)

Interventions

Radiation: Diffusing Alpha Radiation Emitters Therapy (DaRT) DEVICE

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.

DaRT Seeds

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Alpha Tau Medical LTD.: lead

Study Sites (2)

Centre Hospitalier de l'Université de Montréal (CHUM)

Montreal, Quebec, Canada

Location

Jewish General Hospital

Montreal, Quebec, Canada

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• David Donath, MD

  Brachytherapy Service Centre Hospitalier de l'Université de Montreal

  PRINCIPAL INVESTIGATOR

• Corey Miller, MD

  Division of Gastroenterology, Jewish General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2019
• First Posted: June 28, 2019
• Study Start: October 20, 2020
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: December 2, 2025

Record last verified: 2025-11

Locations

CA (2)