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Spots Global Cancer Trial Database for Alpha Radiation Emitters Device for the Treatment of Squamous Cell Carcinoma (DaRT)

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Trial Identification

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

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

Study ID: NCT03353077

Study Description

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

Detailed 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).

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (I.R.S.T.), Meldola, , Italy

Contact Details

Useful links and downloads for this trial

Clinicaltrials.gov

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