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

NCT06698458 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-05-06

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Alpha Tau Medical LTD.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
120 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-17
Primary Completion
2026-10-31
Completion
2026-12-31
FDA Device
Yes

Countries

  • United States
  • Canada
  • Israel

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06698458 on ClinicalTrials.gov