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Spots Global Cancer Trial Database for Retreatment With Intratumoral Diffusing Alpha Radiation Emitters

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Trial Identification

Brief Title: Retreatment With Intratumoral Diffusing Alpha Radiation Emitters

Official Title: A Safety and Efficacy Study of Retreatment With Intratumoral Diffusing Alpha Radiation Emitters

Study ID: NCT04540588

Study Description

Brief Summary: A unique approach for cancer treatment employing intratumoral diffusing alpha radiation emitter device for superficial cutaneous, mucosal or soft tissue neoplasia

Detailed Description: This will be a prospective, open label, single arm, controlled study, assessing the safety and efficacy of re-treatment with 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. Superficial lesions with histopathological confirmation of either recurrent or persistent disease following DaRT treatment. . Reduction in tumor size 70 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

Sharett institute, Hadassah University Hospital - Ein-Kerem, Jerusalem, , Israel

Contact Details

Name: Aron Popovtzer, M.D

Affiliation: Sharett institute, Hadassah Medical Center - Ein-Kerem

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

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