RecruitingNot ApplicableNCT06698458

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

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


Sponsor

Alpha Tau Medical LTD.

Enrollment

40 participants

Start Date

Jun 17, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 120 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a device that delivers targeted radiation from inside a tumor (called Alpha DaRT) combined with standard chemotherapy for people with advanced pancreatic cancer that cannot be surgically removed. **You may be eligible if...** - You have been newly diagnosed with locally advanced, inoperable pancreatic cancer, OR newly diagnosed metastatic pancreatic cancer confirmed by biopsy - You will receive up to 4 cycles of standard chemotherapy (mFOLFIRINOX) before the device is inserted - Your tumor is technically accessible for the device implant - Your tumor has a measurable lesion no larger than 5 cm **You may NOT be eligible if...** - You have previously received chemotherapy or radiation for this cancer - Your tumor is not accessible for the device procedure - You have significant organ dysfunction that would prevent safe treatment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICERadiation: Diffusing Alpha Radiation Emitters Therapy (DaRT)

DaRT source will be inserted using endoscopy into the tumor. The sources release by recoil into the tumor short-lived alpha-emitting atoms


Locations(15)

Banner MD Anderson Cancer Center

Gilbert, Arizona, United States

City of Hope

Goodyear, Arizona, United States

Honor Health

Scottsdale, Arizona, United States

Cedars-Sinai

Los Angeles, California, United States

Advent Health Cancer Institute

Orlando, Florida, United States

Emory University

Atlanta, Georgia, United States

Bassett Healthcare Network

Cooperstown, New York, United States

NYU Langone Health

New York, New York, United States

Lenox hill Hospital

New York, New York, United States

Montefiore Medical Center

The Bronx, New York, United States

Texas Oncology

Houston, Texas, United States

Baylor College of Medicine

Houston, Texas, United States

University Cancer and Diagnostic

Houston, Texas, United States

Jewish General Hospital

Montreal, Quebec, Canada

Hadassah Ein Kerem

Jerusalem, Israel

View Full Details on ClinicalTrials.gov

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NCT06698458


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