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

  • STATUS
    Recruiting
  • participants needed
    15
  • sponsor
    Alpha Tau Medical LTD.
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Updated on 24 November 2025
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Summary

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

Description

This is a Prospective, interventional, open label, single arm, multiple center study. The study is designed to evaluate the feasibility and safety of the DaRT seeds for the treatment of advanced pancreatic cancer.

The study will be comprised of a screening period, DaRT insertion visit, acute follow-up phase of 4- 8 weeks and a long-term follow up phase of 3 months. The total duration of the study will be 3 months from the DaRT insertion procedure.

15 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. The patients will be monitored for a period of 3 months post insertion

Details
Condition Pancreatic Cancer, Unresectable Pancreatic Cancer, Metastatic Pancreatic Cancer, Pancreatic Adenocarcinoma
Age 18years or above
Clinical Study IdentifierNCT05657743
SponsorAlpha Tau Medical LTD.
Last Modified on24 November 2025

Eligibility

 Yes No Not Sure

Inclusion Criteria

Histologically and/or cytologically proven locally advanced or metastatic pancreatic adenocarcinoma
Patients must have i) received at least one line of chemotherapy 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
Target lesion is technically amenable for at least 50% coverage by the Alpha DaRT seeds as determined by the treating physician
Interstitial radiation indication validated by a multidisciplinary team
Measurable lesion per RECIST (version 1.1) criteria
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 ≥ 60cc/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
Brain metastases
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 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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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