Alpha Radiation Emitters Device for the Treatment of Advanced Pancreatic Cancer
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|ClinicalTrials.gov Identifier: NCT04002479|
Recruitment Status : Recruiting
First Posted : June 28, 2019
Last Update Posted : March 17, 2021
|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Cancer Unresectable Pancreatic Cancer Metastatic Pancreatic Cancer Pancreatic Adenocarcinoma||Device: Radiation: Diffusing Alpha Radiation Emitters Therapy (DaRT)||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Feasibility and Safety Study of Intratumoral Diffusing Alpha Radiation Emitters on Advanced Pancreatic Cancer|
|Actual Study Start Date :||October 20, 2020|
|Estimated Primary Completion Date :||October 2022|
|Estimated Study Completion Date :||October 2024|
Experimental: DaRT Seeds
Intratumoral Diffusing alpha-emitters Radiation Therapy (DaRT) Seeds
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.
- Feasibility - DaRT seed placement [ Time Frame: Day 0 (Day of insertion) ]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.
- Safety - Adverse events [ Time Frame: 3 months ]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
- Safety - Adverse events [ Time Frame: 3 to 24 months ]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
- Efficiency - Short-term effect [ Time Frame: 4-6 weeks after DaRT seeds insertion ]Assessment of the objective response rate (ORR) following DaRT seeds insertion using CT scan
- Tissue damage evaluation [ Time Frame: Day -14 to 60 days after insertion ]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).
- Efficiency - Long-term effect [ Time Frame: 2 years following DaRT seeds insertion ]Assessment of the overall survival (OS) following DaRT seeds insertion
- Stent durability [ Time Frame: Day of DaRT insertion up to 24 months. ]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
- Change in quality of life: EORTC-QLQ-C30 [ Time Frame: Day -14 to 60 days after insertion ]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).
- Change in quality of life: QLQ-PAN26 [ Time Frame: Day -14 to 60 days after insertion ]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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04002479
|Contact: Naama Barel||+972-3-618-24770||Naamab@alphatau.com|
|Contact: Amnon Gat||+1(617)435-6552||Amnong@alphatau.com|
|Centre Hospitalier de l'Université de Montréal (CHUM)||Recruiting|
|Montréal, Quebec, Canada|
|Contact: David Donath, MD|
|Principal Investigator:||David Donath, MD||Brachytherapy Service Centre Hospitalier de l'Université de Montreal|