Alpha Radiation Emitters Device for the Treatment of Advanced Pancreatic Cancer

Official Title

A Feasibility and Safety Study of Intratumoural Diffusing Alpha Radiation Emitters on Advanced Pancreatic Cancer

Summary:

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

Trial Description

Primary Outcome:

  • Feasibility - DaRT seed placement
  • Safety - Adverse events
  • Safety - Adverse events
Secondary Outcome:
  • Efficiency - Short-term effect
  • Tissue damage evaluation
  • Efficiency - Long-term effect
  • Stent durability
  • Change in quality of life: EORTC-QLQ-C30
  • Change in quality of life: QLQ-PAN26
This is a prospective, single-centre, open label, single arm study. The study is designed to evaluate the feasibility, safety and preliminary efficacy of intratumoural alpha radiation mediated treatment with Alpha 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 4-6 weeks and a long-term follow up phase of 24 months. The total duration of the study will be 24 months from the DaRT insertion procedure. 30 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 24 months post insertion.

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society