Alpha Radiation Emitters for the Treatment of Pancreatic Cancer for the Treatment of Locally Advanced Pancreatic Cancer

June 15, 2026 updated by: Alpha Tau Medical LTD.

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

A unique approach for cancer treatment employing intratumoral diffusing alpha radiation emitter device for advanced pancreatic cancer

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a prospective, interventional, single-center, open label, single arm study. The study is designed to evaluate the feasibility and Safety of Intratumoral Diffusing Alpha Radiation Emitters for the Treatment of Locally Advanced Pancreatic Cancer

The study will be comprised of a screening period, DaRT insertion visit, 3 months follow up per subject and 2 years for accrual and trial completion. The total duration of the study will be 24 months from the DaRT insertion procedure.

15 patients with a safety interim analysis after the 5 first patients . patients with advanced pancreatic cancer will be recruited by the investigational site.

Eligible patients who meet inclusion/exclusion criteria (as assessed during the screening period) will be invited to the site for the procedure of DaRT seeds insertion.

Study Type

Interventional

Enrollment (Estimated)

15

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

  • Italy
      • Verona, Italy
        • Recruiting
        • Chirurgia Generale e del Pancreas, Istituto del Pancreas
        • Contact:
          • Salvatore Paiella, MD
          • Phone Number: 045-8124553
        • Contact:
          • Erica Secchettin

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 NCCN locally advanced PC
  • Patients must have i) received at least one line of chemotherapy (any kind) OR ii) are medically unfit for further chemotherapy, AND iii) the tumor is still not deemed as resectable with radical surgery, or the patient does not wish to go through surgery.
  • DaRT indication validated by a multidisciplinary team.
  • Measurable lesion per RECIST (version 1.1) criteria
  • TC at Verona's center (not been over a month)
  • Lesion size ≤ 5 cm in the longest diameter
  • Age ≥18 years old
  • ECOG Performance Status Scale ≤ 2
  • Life expectancy is more than 6 months
  • WBC ≥ 3500/μl, granulocyte ≥ 1500/μl
  • Platelet count ≥60,000/μl
  • Calculated or measured creatinine clearance ≥ 30cc/min. Calculated or measured creatinine clearance can be ≥ 40cc/min given stability of creatinine levels over the past three weeks (at least 1 test per week).
  • AST and ALT ≤ 2.5 X upper limit of normal (ULN)
  • INR < 1.4 for patients not on Warfarin
  • 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 brachytherapy.
  • 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 discontinuing therapy.

Exclusion Criteria:

  • Concomitant chemotherapy or immunotherapy within the past 4 weeks
  • Prior radiation therapy to the pancreas
  • CA 19-9 > 1000 Units/ml
  • Fit for surgical exploration unless the 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 (not including cholangitis) 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 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: DaRT seeds insertion
An intratumoral insertion of radioactive sources [Ra-224 containing stainless-steel 316LVM tubes- (Alpha DaRT seeds)]. The seeds release by recoil into the tumor short-lived alpha-emitting atoms
Other Names:
  • Device: Radiation: Diffusing Alpha Radiation Emitters Therapy (DaRT)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility- DaRT seed placement
Time Frame: Immediately following the insertion procedure
Feasibility will be determined according to the rate of successful placement of DaRT seeds via imaging
Immediately following the insertion procedure
Safety- Adverse events, Safety will be determined according to the overall incidence of device-related SAE's graded according to CTCAE v5.0 criteria
Time Frame: from DaRT-insertion up to 48 hours
Safety will be determined according to the overall incidence of device-related SAE's graded according to CTCAE v5.0 criteria
from DaRT-insertion up to 48 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To evaluate the Efficacy of the Alpha DaRT seeds for locally advanced pancreatic cancer
Time Frame: 1 months and 3 months
Local control evaluation according to RECIST v1.1
1 months and 3 months
To evaluate the Efficacy of the Alpha DaRT seeds by measuring the CA-19-9 markers levels
Time Frame: 1 months and 3 months
Change in CA 19-9 levels
1 months and 3 months
Efficacy - to evaluate what is the percent of the Tumor Coverage by the Alpha DaRT seeds
Time Frame: immediately following the insertion procedure]
Tumor Coverage
immediately following the insertion procedure]
Efficacy- Alpha DaRT seeds
Time Frame: from DaRT-insertion up to initiation of a possible postablation therapy or up to a maximum three months
Overall incidence of device-related SAE's graded according to CTCAE v5.0 criteria
from DaRT-insertion up to initiation of a possible postablation therapy or up to a maximum three months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Exploratory Objective -to evaluate the changes in the immune markers by Blood samples for immune response
Time Frame: 1 month

Changes in immune markers following treatment ,These biomarkers include:

  • CD3
  • CD4
  • CD8
  • CD69
  • CD137
1 month

Collaborators and Investigators

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

Sponsor

Alpha Tau Medical LTD.

Investigators

  • Principal Investigator: Salvatore Paiella, MD, Pancreas Institute - Integrated University Hospital of Verona

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)

May 6, 2026

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

January 1, 2028

Study Registration Dates

First Submitted

August 17, 2023

First Submitted That Met QC Criteria

September 5, 2023

First Posted (Actual)

September 7, 2023

Study Record Updates

Last Update Posted (Actual)

June 16, 2026

Last Update Submitted That Met QC Criteria

June 15, 2026

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CTP-PANC-03

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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