Alpha Radiation Emitters Device for the Treatment of Squamous Cell Carcinoma

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.

Detailed Description
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This will be a prospective, first in man, 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. Lesions with histopathological diagnosis of squamous cell carcinoma will be studied. Reduction in tumor size 30 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 (First in Man)

Conditions
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Squamous Cell Carcinoma

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histopathological confirmation of squamous cell carcinoma. Tumor size ≤ 5 centimeters in the longest diameter. Age over 18. Women of childbearing potential will have evidence of negative pregnancy test. Life expectancy of more than 6 months. Performance status 2 (ECOG scale) or less. Signed informed consent form. Exclusion Criteria: Tumor maximal diameter > 5 centimeters. Tumor of Keratoacanthoma histology. Performance status ≥ 3 (ECOG scale). Patients with moribund diseases, autoimmune diseases or vasculitis. Patients under immunosuppressive and/or corticosteroid treatment. Volunteers that participated in other studies in the past 30 days.

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: Diffusing Alpha Radiation Emitters Therapy (DaRT)<br>Intratumoral Diffusing alpha-emitters Radiation Therapy (DaRT) Seed Devices | 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 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 Cancer, Squamous Cell Carcinoma, Alpha emitting radiation, Carcinoma, Squamous, HNSCC