Retreatment With Intratumoral Diffusing Alpha Radiation Emitters

  • End date
    Jan 1, 2026
  • participants needed
  • sponsor
    Alpha Tau Medical LTD.
Updated on 25 March 2022
platelet count
measurable disease
cancer treatment


A unique approach for cancer treatment employing intratumoral diffusing alpha radiation emitter device for superficial cutaneous, mucosal or soft tissue neoplasia


This will be a prospective, open label, single arm, controlled study, assessing the safety and efficacy of re-treatment with diffusing alpha emitters radiation therapy (DaRT) delivered through radioactive seeds inserted into the tumor.

This approach combines the advantages of local intratumoral irradiation of the tumor, as used in conventional brachytherapy, with the power of the alpha radiation emitting atoms, that will be introduced in quantities considerably lower than radiation therapy already used in patients.

Superficial lesions with histopathological confirmation of either recurrent or persistent disease following DaRT treatment. .

Reduction in tumor size 70 days after DaRT insertion will be assessed. Safety will be assessed by the incidence, severity and frequency of all Adverse Events (AE).

Condition Skin Cancer, Mucosal Neoplasm of Oral Cavity, Soft Tissue Neoplasm
Treatment Radiation: Diffusing Alpha Radiation Emitters Therapy (DaRT)
Clinical Study IdentifierNCT04540588
SponsorAlpha Tau Medical LTD.
Last Modified on25 March 2022


Yes No Not Sure

Inclusion Criteria

Subjects with histopathological confirmation of either recurrent or persistent disease following DaRT treatment
Subjects with a tumor size ≤ 5 centimeters in the longest diameter
Target lesion technically amenable for full coverage with the Alpha DaRT seeds
Brachytherapy indication validated by a multidisciplinary team
Measurable disease according to RECIST v1.1
Subjects over 18 years old
Subjects' ECOG Performance Status Scale is < 2\
Subjects' life expectancy is more than 6 months
Platelet count ≥100,000/mm3
AST and ALT ≤ 2.5 X ULN
WBC ≥ 3500/μl, granulocyte ≥ 1500/μl
International normalized ratio of prothrombin time ≤1.4 for patients not on Warfarin
Creatinine ≤2.3 mg/dL
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
Subjects are willing to sign an informed consent form

Exclusion Criteria

Patients undergoing systemic immunosuppressive therapy excepting intermittent, brief use of systemic corticosteroids
Known hypersensitivity to any of the components of the treatment
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
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
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)
Subjects not willing to sign an informed consent
Women who are pregnant or breastfeeding
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact



Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

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.

Learn more

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

Learn more

Similar trials to consider


Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 



Reply by • Private

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note