Alpha Radiation Emitters Device for the Treatment of Squamous Cell Carcinoma

A Safety and Effectiveness Study of Intratumoral Diffusing Alpha Radiation Emitters on Squamous Cell Carcinoma (First in Man)

A unique approach for cancer treatment employing intratumoral diffusing alpha radiation emitter device.

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).

Inclusion Criteria:

1. Histopathological confirmation of squamous cell carcinoma.
2. Tumor size ≤ 5 centimeters in the longest diameter.
3. Age over 18.
4. Women of childbearing potential will have evidence of negative pregnancy test.
5. Life expectancy of more than 6 months.
6. Performance status 2 (ECOG scale) or less.
7. Signed informed consent form.

Exclusion Criteria:

1. Tumor maximal diameter > 5 centimeters.
2. Tumor of Keratoacanthoma histology.
3. Performance status ≥ 3 (ECOG scale).
4. Patients with moribund diseases, autoimmune diseases or vasculitis.
5. Patients under immunosuppressive and/or corticosteroid treatment.
6. Volunteers that participated in other studies in the past 30 days.