Alpha Radiation Emitters Device for the Treatment of Cutaneous Mucosal and Superficial Soft Tissue Neoplasia (DaRT)

  • End date
    Sep 27, 2022
  • participants needed
  • sponsor
    Alpha Tau Medical LTD.
Updated on 27 July 2021
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 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 malignancy will be treated using DaRT seeds.

Reduction in tumor volume and evaluation the percent of necrotic tissue in the tumor 30-45 days after DaRT seeds insertion (15-30 days after seed removal) will be assessed. Safety will be assessed by the cumulative incidence, worst severity and frequency of adverse events (AEs) observed including the follow-up period.

Condition Soft tissue tumor, melanoma, skin cancer, Mucosal Neoplasm of Oral Cavity, soft tissue tumour, soft tissue tumors, skin cancers
Treatment Device: Radiation: Diffusing Alpha Radiation Emitters Therapy (DaRT)
Clinical Study IdentifierNCT03886181
SponsorAlpha Tau Medical LTD.
Last Modified on27 July 2021


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Inclusion Criteria

Subjects with histopathological confirmation of cutaneous and/or mucosal and/or superficial soft tissue malignant neoplasia
Subjects with a tumor size 5 centimeters in the longest diameter
Subjects' age is over 18 years old
Subjects' ECOG Performance Status Scale is < 2\
Subjects' life expectancy is more than 6 months
Women of childbearing potential (WOCBP) will have evidence of negative pregnancy test
Subjects are able and willing to sign an informed consent form

Exclusion Criteria

Subject has a tumor with a maximal diameter > 5 centimeters
Subjects' ECOG Performance Status Scale is > 3\
Subject has a tumor of Keratoacanthoma histology
Patients with moribund diseases, e.g., autoimmune diseases, vasculitis, etc
Patients under systemic immunosuppressive and/or corticosteroid treatment. Patients taking corticosteroid inhalers are eligible
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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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