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Alpha Radiation Emitters (DaRT) with Chemotherapy for Pancreatic Cancer

This study is testing a new treatment called Diffusing Alpha Radiation Emitters Therapy (DaRT) along with standard chemotherapy (mFOLFIRINOX or Gemcitabine/Abraxane) for people with newly diagnosed pancreatic cancer. DaRT involves inserting a device into the tumor that releases short-lived alpha-emitting atoms to fight the cancer. The study aims to understand how safe DaRT is when combined with chemotherapy, looking at any serious side effects over 24 months. Researchers will also assess how well the treatment works to control the cancer and pain, and if it helps make surgery possible for some patients. You may be able to join if you are 18 or older and have either locally advanced or metastatic pancreatic adenocarcinoma that has been confirmed by a biopsy.

Study design
This is an open-label study with two groups of participants, enrolling up to 30 people in total. It is not specified if this study is randomized or what phase it is in.
What's involved
Participants will start with up to 4 cycles of chemotherapy (mFOLFIRINOX or Gemcitabine/Abraxane) before the DaRT device is inserted into the tumor.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for safety outcomes for up to 24 months after the start of treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06698458

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

Recruiting
NAAges 18+InterventionalTreatment
Alpha Tau Medical LTD.
~50 participants
Updated 2026-08-27 on ClinicalTrials.gov
What's tested:Radiation: Diffusing Alpha Radiation Emitters Therapy (DaRT)

At a glance

Recruiting sites
10 of 15 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety -Serious adverse events
Measured over From Day 0 ,up to study termination

Conditions

Pancreatic Cancer
Pancreatic Adenocarcinoma
Metastatic Pancreatic Cancer

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Where you'd take part

This study runs at 15 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Advent Health Cancer Institute

    Orlando, Floridastudy coordinator listed

    Not yet recruiting

  • Banner MD Anderson Cancer Center

    Gilbert, Arizonastudy coordinator listed

    Recruiting

  • Bassett Healthcare Network

    Cooperstown, New Yorkstudy coordinator listed

    Recruiting

  • Baylor College of Medicine

    Houston, Texasstudy coordinator listed

    Recruiting

  • Cedars-Sinai

    Los Angeles, Californiastudy coordinator listed

    Not yet recruiting

  • City of Hope

    Goodyear, Arizonastudy coordinator listed

    Not yet recruiting

  • Hadassah Ein Kerem

    Jerusalem, Israelstudy coordinator listed

    Recruiting

  • Honor Health

    Scottsdale, Arizonastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Liron Dimnik · STUDY_DIRECTOR · Alpha Tau Medical

Who to contact

Liron Dimnik
[email protected]
+972-2-3737-7000
Email the study team

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Eligibility criteria

Inclusion

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

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.
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.

What this trial measures

  • Safety -Serious adverse eventsFrom Day 0 ,up to study termination

    The primary endpoint is the incidence , rate and severity of treatment- emergent Adverse Events (TEAS) graded according to CTCAE V6.0.