The classic website will no longer be available as of June 25, 2024. Please use the modernized ClinicalTrials.gov.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Alpha Radiation Emitters Device for the Treatment of Advanced Pancreatic Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04002479
Recruitment Status : Recruiting
First Posted : June 28, 2019
Last Update Posted : January 31, 2024
Sponsor:
Information provided by (Responsible Party):
Alpha Tau Medical LTD.

Tracking Information
First Submitted Date  ICMJE June 16, 2019
First Posted Date  ICMJE June 28, 2019
Last Update Posted Date January 31, 2024
Actual Study Start Date  ICMJE October 20, 2020
Estimated Primary Completion Date October 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 27, 2019)
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 4, 2019)
  • 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).
Original Secondary Outcome Measures  ICMJE
 (submitted: June 27, 2019)
  • 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 -14-0 (+/-14), 6 (+/-3), 35 (+/-7), 60 (+/-7) ]
    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 -14-0 (+/-14), 6 (+/-3), 35 (+/-7), 60 (+/-7) ]
    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 -14-0 (+/-14), 6 (+/-3), 35 (+/-7), 60 (+/-7) ]
    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).
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Alpha Radiation Emitters Device for the Treatment of Advanced Pancreatic Cancer
Official Title  ICMJE A Feasibility and Safety Study of Intratumoral Diffusing Alpha Radiation Emitters on Advanced Pancreatic Cancer
Brief 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Pancreatic Cancer
  • Unresectable Pancreatic Cancer
  • Metastatic Pancreatic Cancer
  • Pancreatic Adenocarcinoma
Intervention  ICMJE 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.
Study Arms  ICMJE Experimental: DaRT Seeds
Intratumoral Diffusing alpha-emitters Radiation Therapy (DaRT) Seeds
Intervention: Device: Radiation: Diffusing Alpha Radiation Emitters Therapy (DaRT)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 12, 2023)		 37
Original Estimated Enrollment  ICMJE
 (submitted: June 27, 2019)		 30
Estimated Study Completion Date  ICMJE October 2026
Estimated Primary Completion Date October 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Liron Dimnik +972-2-373-7000 LironD@alphatau.com
Contact: Amnon Gat +1(617)435-6552 Amnong@alphatau.com
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04002479
Other Study ID Numbers  ICMJE AT-PANC-101
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Alpha Tau Medical LTD.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Alpha Tau Medical LTD.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: David Donath, MD Brachytherapy Service Centre Hospitalier de l'Université de Montreal
Principal Investigator: Corey Miller, MD Division of Gastroenterology, Jewish General Hospital
PRS Account Alpha Tau Medical LTD.
Verification Date April 2023

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP