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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04002479
Other study ID # AT-PANC-101
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 20, 2020
Est. completion date October 2026

Study information

Verified date April 2023
Source Alpha Tau Medical LTD.
Contact Liron Dimnik
Phone +972-2-373-7000
Email LironD@alphatau.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 37
Est. completion date October 2026
Est. primary completion date October 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

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.

Locations

Country Name City State
Canada Centre Hospitalier de l'Université de Montréal (CHUM) Montréal Quebec
Canada Jewish General Hospital Montréal Quebec

Sponsors (1)

Lead Sponsor Collaborator
Alpha Tau Medical LTD.

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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)
Primary 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
Primary 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 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
Secondary 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
Secondary Efficiency - Long-term effect Assessment of the overall survival (OS) following DaRT seeds insertion 2 years following DaRT seeds insertion
Secondary 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.
Secondary 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
Secondary 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
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