Trials / Active Not Recruiting
Active Not RecruitingNCT04002479
Alpha Radiation Emitters Device for the Treatment of Advanced Pancreatic Cancer
A Feasibility and Safety Study of Intratumoral Diffusing Alpha Radiation Emitters on Advanced Pancreatic Cancer
- Status
- Active Not Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 37 (estimated)
- Sponsor
- Alpha Tau Medical LTD. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
A unique approach for cancer treatment employing intratumoral diffusing alpha radiation emitter device for advanced pancreatic cancer.
Detailed description
This is a prospective, single-center, open label, single arm study. The study is designed to evaluate the feasibility, safety and preliminary efficacy of intratumoral 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.
Conditions
- Pancreatic Cancer
- Unresectable Pancreatic Cancer
- Metastatic Pancreatic Cancer
- Pancreatic Adenocarcinoma
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Radiation: Diffusing Alpha Radiation Emitters Therapy (DaRT) | 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. |
Timeline
- Start date
- 2020-10-20
- Primary completion
- 2026-10-01
- Completion
- 2026-10-01
- First posted
- 2019-06-28
- Last updated
- 2025-12-02
Locations
2 sites across 1 country: Canada
Source: ClinicalTrials.gov record NCT04002479. Inclusion in this directory is not an endorsement.