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

Alpha Tau Medical

Status

Enrolling

Conditions

Soft Tissue Neoplasm

Mucosal Neoplasm of Oral Cavity

Skin Cancer

Treatments

Device: Radiation: Diffusing Alpha Radiation Emitters Therapy (DaRT)

Study type

Interventional

Funder types

Industry

Identifiers

NCT03889899

CTP-CMN-03

Details and patient eligibility

About

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

Full description

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

Enrollment

30 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Subjects with histopathological confirmation of primary or secondary malignant cutaneous neoplastic lesions, or oral cavity mucosal tumors, or superficial soft tissue sarcoma.
Subjects with a tumor size ≤ 7 centimeters in the longest diameter.
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.
Creatinine ≤1.9 mg/dL.
Women of childbearing potential (WOCBP) will have evidence of negative pregnancy test.
Subjects are willing to sign an informed consent form.

Exclusion criteria

Subject has a tumor of Keratoacanthoma histology.
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.