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

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

Detailed Description
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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.

Official Title
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A Safety and Preliminary Effectiveness Study of Intratumoral Diffusing Alpha Radiation Emitters on Cutaneous, Mucosal and Superficial Soft Tissue Neoplasia

Conditions
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Skin Cancer, Mucosal Neoplasm of Oral Cavity, Soft Tissue Neoplasm

Intervention / Treatment
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* Device: Device: Radiation: Diffusing Alpha Radiation Emitters Therapy (DaRT)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DaRT Seeds<br>Intratumoral Diffusing alpha-emitters Radiation Therapy (DaRT) Seeds | Device: Device: Radiation: Diffusing Alpha Radiation Emitters Therapy (DaRT)<br>* An intratumoral insertion of a seed(s), loaded with Radium-224, securely fixed in the seeds. The seeds release by recoil into the tumor short-lived alpha-emitting atoms.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the safety of the DaRT treatment | The study primary objective is to evaluate the safety of the DaRT treatment in terms of incidence of device related Serious Adverse Events (SAE). | 5-7 weeks after DaRT seed insertion. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation the effectiveness of the treatment. | Evaluation on the effectiveness of the DaRT treatment, in terms of tumor volume reduction. | Tumor volume will be measured during screening, 5 and 30-45 days post DaRT after treatment using CT. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Squamous Cell Carcinoma, SCC, Skin Cancer, Skin metastasis, HNSCC, Carcinoma, Squamous, CMN, Basal cell carcinoma, Superficial sarcoma, Kaposi sarcoma, Alpha radiation, Cutaneous lesion, Tongue cancer, Lip cancer