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2020-10-20
2025-10
2026-10
37
NCT04002479
Alpha Tau Medical LTD.
Alpha Tau Medical LTD.
INTERVENTIONAL
Alpha Radiation Emitters Device for the Treatment of Advanced Pancreatic Cancer
A unique approach for cancer treatment employing intratumoral diffusing alpha radiation emitter device for advanced pancreatic cancer.
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.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2019-06-16 | N/A | 2024-11-19 |
2019-06-27 | N/A | 2024-11-20 |
2019-06-28 | N/A | 2024-11 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Na
Interventional Model:
Single Group
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| EXPERIMENTAL: DaRT Seeds Intratumoral Diffusing alpha-emitters Radiation Therapy (DaRT) Seeds | DEVICE: Radiation: Diffusing Alpha Radiation Emitters Therapy (DaRT)
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| 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 Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Efficiency - Short-term effect | Assessment of the objective response rate (ORR) following DaRT seeds insertion using CT scan | 4-6 weeks after DaRT seeds insertion |
| Tissue damage evaluation | Measuring CA19-9 as a marker to tissue damage. Elevation during treatment, and reduction as a result of tumor ablation. Serum levels of CA 19-9 can be measured using chemiluminescent assay on an Unicel DxI 800 analyzer (BeckmanCoulter, Brea, CA, USA). | Day -14 to 60 days after insertion |
| Efficiency - Long-term effect | Assessment of the overall survival (OS) following DaRT seeds insertion | 2 years following DaRT seeds insertion |
| Stent durability | Stent durability will be assessed by the time elapsed from DaRT insertion to the need for follow-up referral for ERCP for stent change due to tumor ingrowth | Day of DaRT insertion up to 24 months. |
| Change in quality of life: EORTC-QLQ-C30 | Assessment of patient reported health-related Quality of Life (QoL) outcomes after DaRT treatment, using QoL questionnaires EORTC-QLQ-C30 (version 3.0). Scale range in score from 0 (best) to 100(worst). | Day -14 to 60 days after insertion |
| Change in quality of life: QLQ-PAN26 | Assessment of patient reported health-related Quality of Life (QoL) outcomes after DaRT treatment, using QoL questionnaires QLQ-PAN26. The module comprises 26 questions assessing pain, dietary changes, jaundice, altered bowel habit, emotional problems related to pancreatic cancer, and other symptoms (cachexia, indigestion, flatulence, dry mouth, taste changes). | Day -14 to 60 days after insertion |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
|
Study Contact Name: Liron Dimnik Phone Number: +972-2-373-7000 Email: LironD@alphatau.com |
Study Contact Backup Name: Amnon Gat Phone Number: +1(617)435-6552 Email: Amnong@alphatau.com |
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
