RECRUITING

Alpha Radiation Emitters Device for the Treatment of Pancreatic Cancer Emitters With Chemotherapy for the Treatment of Locally Advanced and Metastatic Pancreatic Cancer

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Conditions

Pancreatic CancerPancreatic AdenocarcinomaMetastatic Pancreatic CancerAlpha radiationUnresectable Pancreatic Cancer

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This is a multi-center clinical study enrolling up to 30 participants (15 patients in each cohort). The primary objective of the study is to evaluate the safety of Alpha DaRT in combination with chemotherapy, based on the cumulative incidence rate, severity and outcome of device related AEs. Classification of AEs will be done according to CTCAE V5. The secondary objectives of the study are to: * Assess efficacy of the Alpha DaRT sources in combination with chemotherapy, determined by overall and progression-free survival. * Assess pain control * Assess rate of surgical resection in Cohort 1.

Official Title

A Study to Assess the Safety of Intratumoral Diffusing Alpha Radiation Emitters With Chemotherapy for the Treatment of Locally Advanced and Metastatic Pancreatic Cancer

Quick Facts

Study Start:2025-06-17
Study Completion:2026-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06698458

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 120 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Histologically and/or cytologically proven newly diagnosed locally advanced inoperable pancreatic adenocarcinoma (Cohort 1) OR histologically and/or cytologically proven newly diagnosed metastatic pancreatic adenocarcinoma (Cohort 2).
  2. * Patients will start treatment with mFOLFIRINOX (up to 4 cycles) before DaRT insertion
  3. * Target lesion is technically amenable for Alpha DaRT sources implantation.
  4. * Measurable lesion per RECIST (version 1.1) criteria
  5. * Lesion size ≤ 5 cm in the longest diameter
  6. * Interstitial radiation indication validated by a multidisciplinary team.
  7. * ECOG Performance Status Scale 0 -2
  8. * Life expectancy is more than 6 months
  9. * WBC ≥ 3500/μl, granulocyte ≥ 1500/μl
  10. * Platelet count ≥60,000/μl
  11. * Creatinine ≤1.9 mg/dL
  12. * AST and ALT ≤ 2.5 X upper limit of normal (ULN)
  13. * INR \< 1.4 for patients not on Warfarin
  14. * Age ≥18 years old
  15. * Subjects are willing and able to sign an informed consent form
  16. * Women of childbearing potential (WOCBP) will have evidence of negative pregnancy test before the Ra-224 implantation and are required to use an acceptable contraceptive method to prevent pregnancy for 3 months after initiation of Alpha DaRT therapy.
  17. * Patients must agree to use adequate contraception (vasectomy or barrier method of birth control) prior to study entry, for the duration of study participation and for 3 months after DaRT insertion.
  1. * For Cohort 1 only: Borderline unresectable pancreatic cancer, and/or fit for surgical exploration unless patient refuses surgery.
  2. * For Cohort 1 and Cohort 2: Prior treatment for pancreatic cancer, including chemotherapy except for 1 - 4 cycles of mFOLFIRINOX, radiation therapy, immunotherapy, etc.
  3. * Known hypersensitivity to any of the components of the treatment.
  4. * Patients undergoing systemic immunosuppressive therapy excepting intermittent, brief use of systemic corticosteroids.
  5. * Clinically significant cardiovascular disease, e.g. cardiac failure of New York Heart Association classes III-IV, uncontrolled coronary artery disease, cardiomyopathy, uncontrolled arrhythmia, uncontrolled hypertension, or history of myocardial infarction in the last 12 months.
  6. * Patients with uncontrolled intercurrent illnesses including, but not limited to an active infection requiring systemic therapy or a known psychiatric or substance abuse disorder(s) that would interfere with cooperation with the requirements of the trial or interfere with the study endpoints.
  7. * Has a known additional malignancy that is progressing or requires active treatment.
  8. * Patient requires treatment not specified in this protocol which may conflict with the endpoints of this study including evaluation of response or toxicity of DaRT.
  9. * Patients do not agree to use adequate contraception (vasectomy or barrier method of birth control) prior to study entry, for the duration of study participation and for 3 months after DaRT insertion.
  10. * 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.
  11. * High probability of protocol non-compliance (in opinion of investigator).
  12. * Breastfeeding women or women of childbearing potential unwilling or unable to use an acceptable contraceptive method to prevent pregnancy for 3 months after DaRT insertion
  13. * Patients who are at high risk of complications from radiation due to genetic conditions/mutations, inflammatory bowel disease, or connective tissue disease.

Contacts and Locations

Study Contact

Liron Dimnik
CONTACT
+972-2-3737-7000
LironD@alphatau.com

Study Locations (Sites)

Banner MD Anderson Cancer Center
Gilbert, Arizona, 85234
United States
Advent Health Cancer Institute
Orlando, Florida, 32804
United States
Emory University
Atlanta, Georgia, 30308
United States
Mayo Clinic Rochester
Rochester, Minnesota, 55905
United States
Montefiore Medical Center
Bronx, New York, 10467
United States
Bassett Healthcare Network
Cooperstown, New York, 13326
United States

Collaborators and Investigators

Sponsor: Alpha Tau Medical LTD.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-06-17
Study Completion Date2026-12

Study Record Updates

Study Start Date2025-06-17
Study Completion Date2026-12

Terms related to this study

Keywords Provided by Researchers

  • Alpha radiation
  • pancreatic cancer
  • Pancreatic Adenocarcinoma
  • Unresectable Pancreatic Cancer

Additional Relevant MeSH Terms

  • Pancreatic Cancer
  • Pancreatic Adenocarcinoma
  • Metastatic Pancreatic Cancer