Alpha Radiation Emitters (DaRT) With Chemotherapy for the Treatment of Locally Advanced and Metastatic Pancreatic Cancer (NCT06698458)
A Study to Assess the Safety of Intratumoral Diffusing Alpha Radiation Emitters With Chemotherapy for the Treatment of Locally Advanced and Metastatic Pancreatic Cancer
🩺 Plain-English Summary (8th-Grade Level)
This is a multi-center clinical study enrolling up to 50 participants. 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 V6. 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.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (17 items) and avoid the listed exclusions (14 items).
Location: Banner MD Anderson Cancer Center — Gilbert, Arizona
Age range: 18 Years to 120 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- For Cohort 1 only: Borderline unresectable pancreatic cancer, and/or fit for surgical exploration unless patient refuses surgery.
- For Cohort 1 and Cohort 2: Prior treatment for pancreatic cancer, including chemotherapy except for 1 - 4 cycles of mFOLFIRINOX, radiation therapy, immunotherapy, etc.
- Known hypersensitivity to any of the components of the treatment.
- Patients undergoing systemic immunosuppressive therapy excepting intermittent, brief use of systemic corticosteroids.
- 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.
- 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.
- Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy, low risk prostate cancer, or in situ cervical cancer.
- 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.
- 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.
- 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).
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (15 Sites)
- Banner MD Anderson Cancer Center — Gilbert, Arizona
- City of Hope — Goodyear, Arizona
- Honor Health — Scottsdale, Arizona
- Cedars-Sinai — Los Angeles, California
- Advent Health Cancer Institute — Orlando, Florida
- Emory University — Atlanta, Georgia
- Bassett Healthcare Network — Cooperstown, New York
- NYU Langone Health — New York, New York
- Lenox hill Hospital — New York, New York
- Montefiore Medical Center — The Bronx, New York
- Texas Oncology — Houston, Texas
- Baylor College of Medicine — Houston, Texas
- University Cancer and Diagnostic — Houston, Texas
- Jewish General Hospital — Montreal, Quebec
- Hadassah Ein Kerem — Jerusalem,
📞 Contact the Study Coordinator
Phone: +972-2-3737-7000
Email: LironD@alphatau.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.