search
Back to results

Alpha Radiation Emitters Device for the Treatment of Advanced Pancreatic Cancer

Primary Purpose

Pancreatic Cancer, Unresectable Pancreatic Cancer, Metastatic Pancreatic Cancer

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Radiation: Diffusing Alpha Radiation Emitters Therapy (DaRT)
Sponsored by
Alpha Tau Medical LTD.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatic Cancer focused on measuring pancreatic cancer, Unresectable Pancreatic Cancer, Metastatic Pancreatic Cancer, Pancreatic Adenocarcinoma, Pancreas Neoplasm, Alpha radiation, Pancreas Cancer, Pancreas Metastases

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Centre Hospitalier de l'Université de Montréal (CHUM)Recruiting
  • Jewish General HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

DaRT Seeds

Arm Description

Intratumoral Diffusing alpha-emitters Radiation Therapy (DaRT) Seeds

Outcomes

Primary Outcome Measures

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.
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
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

Secondary Outcome Measures

Efficiency - Short-term effect
Assessment of the objective response rate (ORR) following DaRT seeds insertion using CT scan
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).
Efficiency - Long-term effect
Assessment of the overall survival (OS) 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
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).
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).

Full Information

First Posted
June 16, 2019
Last Updated
July 23, 2023
Sponsor
Alpha Tau Medical LTD.
search

1. Study Identification

Unique Protocol Identification Number
NCT04002479
Brief Title
Alpha Radiation Emitters Device for the Treatment of Advanced Pancreatic Cancer
Official Title
A Feasibility and Safety Study of Intratumoral Diffusing Alpha Radiation Emitters on Advanced Pancreatic Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 20, 2020 (Actual)
Primary Completion Date
October 2024 (Anticipated)
Study Completion Date
October 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alpha Tau Medical LTD.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer, Unresectable Pancreatic Cancer, Metastatic Pancreatic Cancer, Pancreatic Adenocarcinoma
Keywords
pancreatic cancer, Unresectable Pancreatic Cancer, Metastatic Pancreatic Cancer, Pancreatic Adenocarcinoma, Pancreas Neoplasm, Alpha radiation, Pancreas Cancer, Pancreas Metastases

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
DaRT Seeds
Arm Type
Experimental
Arm Description
Intratumoral Diffusing alpha-emitters Radiation Therapy (DaRT) Seeds
Intervention Type
Device
Intervention Name(s)
Radiation: Diffusing Alpha Radiation Emitters Therapy (DaRT)
Intervention Description
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 Measure Information:
Title
Feasibility - DaRT seed placement
Description
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.
Time Frame
Day 0 (Day of insertion)
Title
Safety - Adverse events
Description
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
Time Frame
3 months
Title
Safety - Adverse events
Description
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
Time Frame
3 to 24 months
Secondary Outcome Measure Information:
Title
Efficiency - Short-term effect
Description
Assessment of the objective response rate (ORR) following DaRT seeds insertion using CT scan
Time Frame
4-6 weeks after DaRT seeds insertion
Title
Tissue damage evaluation
Description
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).
Time Frame
Day -14 to 60 days after insertion
Title
Efficiency - Long-term effect
Description
Assessment of the overall survival (OS) following DaRT seeds insertion
Time Frame
2 years following DaRT seeds insertion
Title
Stent durability
Description
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
Time Frame
Day of DaRT insertion up to 24 months.
Title
Change in quality of life: EORTC-QLQ-C30
Description
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).
Time Frame
Day -14 to 60 days after insertion
Title
Change in quality of life: QLQ-PAN26
Description
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).
Time Frame
Day -14 to 60 days after insertion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Liron Dimnik
Phone
+972-2-373-7000
Email
LironD@alphatau.com
First Name & Middle Initial & Last Name or Official Title & Degree
Amnon Gat
Phone
+1(617)435-6552
Email
Amnong@alphatau.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Donath, MD
Organizational Affiliation
Brachytherapy Service Centre Hospitalier de l'Université de Montreal
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Corey Miller, MD
Organizational Affiliation
Division of Gastroenterology, Jewish General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier de l'Université de Montréal (CHUM)
City
Montréal
State/Province
Quebec
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Donath, MD
Facility Name
Jewish General Hospital
City
Montréal
State/Province
Quebec
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Corey Miller, MD
Phone
514-340-8144
Email
corey.miller@mcgill.ca

12. IPD Sharing Statement

Learn more about this trial

Alpha Radiation Emitters Device for the Treatment of Advanced Pancreatic Cancer

We'll reach out to this number within 24 hrs