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

May 5, 2026 updated by: Alpha Tau Medical LTD.

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This study will be a prospective, interventional, open label, two cohort, multiple center study to assess the efficacy of Alpha DaRT in combination with chemotherapy. Eligible patients with newly diagnosed pancreatic cancer will be categorized into one of the following two cohorts according to their disease state at baseline and the chemotherapy choice at the physician's discretion:

  1. Cohort 1: Locally advanced pancreatic cancer treated with mFOLFIRINOX or Gemcitabine/Abraxane
  2. Cohort 2: Metastatic pancreatic cancer treated with mFOLFIRINOX or Gemcitabine/Abraxane

Patients will begin mFOLFIRINOX or Gemcitabine/Abraxane treatment depending on their assigned cohort and will undergo DaRT placement during the first 4 cycles of chemotherapy.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

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.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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).
  • Patients will start treatment with mFOLFIRINOX (up to 4 cycles) before DaRT insertion
  • Target lesion is technically amenable for Alpha DaRT sources implantation.
  • Measurable lesion per RECIST (version 1.1) criteria
  • Lesion size ≤ 5 cm in the longest diameter
  • Interstitial radiation indication validated by a multidisciplinary team.
  • ECOG Performance Status Scale 0 -2
  • Life expectancy is more than 6 months
  • WBC ≥ 3500/μl, granulocyte ≥ 1500/μl
  • Platelet count ≥60,000/μl
  • Creatinine ≤1.9 mg/dL
  • AST and ALT ≤ 2.5 X upper limit of normal (ULN)
  • INR < 1.4 for patients not on Warfarin
  • Age ≥18 years old
  • Subjects are willing and able to sign an informed consent form
  • 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.
  • 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.

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).
  • 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
  • Patients who are at high risk of complications from radiation due to genetic conditions/mutations, inflammatory bowel disease, or connective tissue disease.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patients with locally advanced pancreatic adenocarcinoma
Patients will begin mFOLFIRINOX or Gemcitabine/Abraxane treatment and will undergo DaRT placement during the first 4 cycles. Follow-up will continue up to 6 months after enrollment.
Device: Radiation: 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
Other Names:
  • DaRT
Experimental: Patients with metastatic pancreatic adenocarcinoma
Patients will begin mFOLFIRINOX or Gemcitabine/Abraxane treatment and will undergo DaRT placement during the first 4 cycles. Follow-up will continue up to 6 months after enrollment.
Device: Radiation: 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
Other Names:
  • DaRT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety -Serious adverse events
Time Frame: From Day 0 ,up to 24 months.
The primary endpoint is the incidence of treatment-related Serious Adverse Events (SAEs) graded according to CTCAE v5.0
From Day 0 ,up to 24 months.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of locally advanced that became surgically resectable
Time Frame: 6 and 24 months
For cohort 1 only: Percentage of locally advanced patients with tumors that became surgically resectable after DaRT treatment
6 and 24 months
Complete or pain response
Time Frame: 30 days and 2 months post-procedure
Complete or partial pain response at 30 days and 2 months postprocedure as compared to baseline based on average pain scale using BPI-SF (Brief Pain Inventory - Short Form) used to evaluate the severity of a patient's pain, 0-no pain, 1 to 3- mild pain, 4 to 7- moderate pain, 8 to 10- severe pain .
30 days and 2 months post-procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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 Major Dates

Study Start (Actual)

June 17, 2025

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

November 18, 2024

First Submitted That Met QC Criteria

November 19, 2024

First Posted (Actual)

November 21, 2024

Study Record Updates

Last Update Posted (Actual)

May 6, 2026

Last Update Submitted That Met QC Criteria

May 5, 2026

Last Verified

October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CTP-PANC-09

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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