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

Alpha Tau Medical

Status

Terminated

Conditions

Soft Tissue Neoplasm

Mucosal Neoplasm of Oral Cavity

Skin Cancer

Treatments

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

Study type

Interventional

Funder types

Industry

Identifiers

NCT03886181

CTP-CMN-01

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 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.

Enrollment

2 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.