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Alpha Radiation Emitters Device (DaRT) for the Treatment of of Malignant Cutaneous Tumors

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About this study

A unique approach for cancer treatment employing intratumoral diffusing alpha radiation emitter device for Malignant Cutaneous Tumors

Condition
Skin Cancer, Cutaneous Tumor, Cutaneous Metastasis
Tested
DaRT- Diffusing Alpha-emitters Radiation Therapy
Sponsor
Alpha Tau Medical LTD.

Who can join

Age
18 years and older
Sex
All sexes
Healthy volunteers
Not accepted

Inclusion 18

  • Minimum age: 18 years
  • Study condition: Skin Cancer, Cutaneous Tumor, Cutaneous Metastasis
  • Subjects with histopathological confirmation of newly diagnosed (Cohort A) or locally recurrent (Cohort B) malignant cutaneous lesions of the following histopathologies:
  • Lentigo maligna melanoma (Dubreuilh melanoma)
  • Carcinosarcoma
  • Acceptable tumor locations include the following:
  • Skin (facial, scalp, extremities, torso)
  • Eyelids
  • Subjects with a tumor size ≤ 7 centimeters in the longest diameter.
  • Target lesion technically amenable for full tumor coverage with the Alpha DaRT seeds.
  • 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.
  • International normalized ratio of prothrombin time ≤1.8.
  • Women of childbearing potential (WOCBP) will have evidence of negative pregnancy test.
  • Subjects are willing to sign an informed consent form

Exclusion 11

  • Subject has a tumor with histology of one of the following:
  • Keratoacanthoma
  • Merkel cell carcinoma
  • Sarcoma other than carcinosarcoma
  • Metastatic disease (according to the TNM staging system - M1 patients are excluded)
  • Patients with significant comorbidities that the treating physician deems may conflict with the endpoints of the study (e.g., poorly controlled autoimmune diseases, vasculitis, etc.).
  • Patients undergoing systemic immunosuppressive therapy excepting intermittent, brief use of systemic corticosteroids.
  • 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.

Where

2 sites, 2 recruiting

CHU Grenoble Alpes

Grenoble, France

Recruiting

Centre Léon Bérard

Lyon, France

Recruiting

Contact

Potential match only. Final eligibility is determined by the study team.