Alpha Radiation Emitters Device (DaRT) for the Treatment of Locally Advanced Pancreatic Cancer

December 1, 2025 updated by: Alpha Tau Medical LTD.

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

A unique approach for cancer treatment including radioactive sources named Alpha DaRT sources: Ra - 224 coated onto stainless steel tubes inserted into the tumor for the treatment of Locally Advanced Pancreatic Cancer .

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This study will be a prospective, interventional, open label, single arm, multiple center study.

Patients who have been previously treated with 8 - 12 cycles of mFOLFIRINOX will undergo DaRT insertion, with the goal of making their tumor resectable. Three (3) days after DaRT insertion, patients will begin taking Capecitabine for 2 months. Every 2 months after DaRT insertion, the patient will be assessed to determine if their tumor is surgically resectable, if they should continue with therapy, or if they should pause therapy. The trial will end 12 months after DaRT insertion.

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 Contact Backup

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 locally advanced pancreatic adenocarcinoma
  • Target lesion is technically amenable for Alpha DaRT sources implantation.
  • Measurable lesion per RECIST (version 1.1) criteria
  • Stable disease or tumor response per RECIST (version 1.1) criteria compared to before initiation of mFOLFIRINOX
  • Lesion size ≤ 5 cm in the longest diameter
  • Interstitial radiation indication validated by a multidisciplinary team which includes an oncologist, a radiation oncologist, radiologist, gastroenterologist and a surgeon specialized in pancreatic oncology in the case that a surgical emergency occurs during the procedure
  • Patients have received 8 - 12 cycles of mFOLFIRINOX
  • ECOG Performance Status Scale 0 - 1
  • 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:

  • Concomitant immunotherapy within the past 4 weeks.
  • Patients with metastatic disease
  • Borderline unresectable pancreatic cancer, and/or cases fit for surgical exploration unless patient refuses surgery.
  • 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 discontinuing therapy.
  • 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 RT.

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: DaRT Seeds
Intratumoral Diffusing alpha-emitters Radiation Therapy (DaRT) Seeds
Device: Radiation: Diffusing Alpha Radiation Emitters Therapy (DaRT)
Radioactive sources named Alpha DaRT sources: Ra - 224 coated onto titanium tubes inserted into the tumor.

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 12 months
Safety will be determined according to the overall incidence of device related SAEs with severity graded according to CTCAE v5.0 criteria
from Day 0 , up to 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy - tumor response
Time Frame: Day 0 , up to 12 months
to evaluate the efficacy of the Alpha DaRT sources in advanced pancreatic cancer patients with respect according to Objective tumor response rate according to RECIST 1.1
Day 0 , up to 12 months
Efficacy - overall survival
Time Frame: Day 0 , up to 12 months
to evaluate the efficacy of the Alpha DaRT sources in advanced pancreatic cancer patients with respect according to Overall survival
Day 0 , up to 12 months
Efficacy - Progression-free survival
Time Frame: Day 0 , up to 12 months
to evaluate the efficacy of the Alpha DaRT sources in advanced pancreatic cancer patients with respect according to - Progression-free survival
Day 0 , up to 12 months
Efficacy - Percentage of R0/R1 resected patients
Time Frame: Day 0 , up to 12 months
to evaluate the efficacy of the Alpha DaRT sources in advanced pancreatic cancer patients with respect according to Percentage of R0/R1 resected patients
Day 0 , up to 12 months
Efficacy - percentage of patients with tumors that became surgically respectable after DaRT treatment
Time Frame: Day 0 , up to 12 months
to evaluate the efficacy of the Alpha DaRT sources in advanced pancreatic cancer patients with respect according to percentage of patients with tumors that became surgically respectable after DaRT treatment
Day 0 , up to 12 months

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 (Estimated)

January 1, 2026

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

June 1, 2027

Study Registration Dates

First Submitted

December 19, 2024

First Submitted That Met QC Criteria

December 31, 2024

First Posted (Actual)

January 1, 2025

Study Record Updates

Last Update Posted (Actual)

December 2, 2025

Last Update Submitted That Met QC Criteria

December 1, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CTP-PANC-04

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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