Alpha Radiation Emitters Device for the Treatment of Squamous Cell Carcinoma (DaRT)

Study Overview
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Brief Summary
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A unique approach for Skin Squamous Cell Carcinoma (SCC) treatment employing intratumoral diffusing alpha radiation emitter device

Detailed Description
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This will be a prospective study, assessing the safety and effectiveness of intratumoral alpha radiation mediated treatment with Alpha DaRT seeds for the treatment of Skin Squamous Cell Carcinoma (SCC) tumors. Treatment will be delivered through radioactive sources (Alpha DaRT seeds) inserted into the tumors in the skin. 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. Lesions with histopathological diagnosis of squamous cell carcinoma will be studied. Reduction in tumor size 30-45 days after DaRT insertion will be assessed. Safety will be assessed by the incidence, severity and frequency of all Adverse Events (AE).

Official Title
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A Safety and Effectiveness Study of Intratumoral Diffusing Alpha Radiation Emitters on Squamous Cell Carcinoma

Conditions
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Skin Squamous Cell Carcinoma

Intervention / Treatment
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* 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 skin squamous cell carcinoma before surgical removal of the tumor. Subjects with a tumor size ≤ 5 centimeters in the longest diameter (lesions without nodal spread). Subjects' age is over 18 years old. Subjects' ECOG Performance Status Scale is ≤ 2. Subjects' life expectancy is more than 6 months. Female subjects of childbearing age will have evidence of negative pregnancy test. Subjects are willing to sign an informed consent form. Exclusion Criteria: Subject has a tumor with a maximal diameter > 5 centimeters. Subject has an ulcerative lesion. Subject has a tumor of Keratoacanthoma histology. Subjects' ECOG Performance Status Scale is ≥ 3. Patients with moribund diseases, e.g., autoimmune diseases, vasculitis, etc. Patients under immunosuppressive and/or corticosteroid treatment. Volunteers that participated in other studies in the past 30 days that might affect the evaluation of response or toxicity of DaRT. Pregnant women. Subjects not willing to sign an informed consent form.

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
Interventional Model Description: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Alpha DaRT<br>Alpha DaRT Seeds, Diffusing alpha-emitters Radiation Therapy. | 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>* Other names: DaRT;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events | The incidence, severity and frequency of all Adverse Events | 30-45 days post seed insertion | 
| Reduction in Tumor size | The reduction in tumor size 30-45 days after DaRT insertion | 30-45 days post seed insertion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of NecroticTissue | Percent of necrotic tissue in the tumor 30-45 days after DaRT insertion | 30-45 days post seed insertion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Skin SCC, Skin Carcinoma, Squamous