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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
Sponsor:
Information provided by (Responsible Party):
Alpha Tau Medical LTD.

Brief Summary:
A unique approach for cancer treatment employing intratumoral diffusing alpha radiation emitter device for advanced pancreatic cancer.

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

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.

  2. 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

  3. 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


Secondary Outcome Measures :
  1. 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

  2. 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).

  3. Efficiency - Long-term effect [ Time Frame: 2 years following DaRT seeds insertion ]
    Assessment of the overall survival (OS) following DaRT seeds insertion

  4. 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

  5. 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).

  6. 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).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Contacts
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Contact: Naama Barel +972-3-618-24770 Naamab@alphatau.com
Contact: Amnon Gat +1(617)435-6552 Amnong@alphatau.com

Locations
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Canada, Quebec
Centre Hospitalier de l'Université de Montréal (CHUM) Recruiting
Montréal, Quebec, Canada
Contact: David Donath, MD         
Sponsors and Collaborators
Alpha Tau Medical LTD.
Investigators
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Principal Investigator: David Donath, MD Brachytherapy Service Centre Hospitalier de l'Université de Montreal
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Responsible Party: Alpha Tau Medical LTD.
ClinicalTrials.gov Identifier: NCT04002479    
Other Study ID Numbers: AT-PANC-101
First Posted: June 28, 2019    Key Record Dates
Last Update Posted: March 17, 2021
Last Verified: March 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Alpha Tau Medical LTD.:
pancreatic cancer
Unresectable Pancreatic Cancer
Metastatic Pancreatic Cancer
Pancreatic Adenocarcinoma
Pancreas Neoplasm
Alpha radiation
Pancreas Cancer
Pancreas Metastases
Additional relevant MeSH terms:
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Adenocarcinoma
Pancreatic Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases