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

Skin Squamous Cell Carcinoma Clinical Trial

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

Clinical Trial Summary

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

Clinical Trial Description

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). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03353077
Study type Interventional
Source Alpha Tau Medical LTD.
Contact
Status Completed
Phase N/A
Start date November 21, 2017
Completion date July 14, 2019
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