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Radiation Therapy (HB-001) by Alpha-particle Sources for Recurrent Malignant Solid Tumors in Japan

Breast Cancer Clinical Trial

Official title:
Study of the Safety and Efficacy of Radiation Therapy (HB-001) by Alpha-particle Sources for Recurrent Malignant Solid Tumors in Japan

Clinical Trial Summary

An intratumoral alpha particle based approach for cancer treatment using diffusion alpha-emitting radiation therapy (DaRT)

Clinical Trial Description

This will be a prospective, open label, single arm, 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. Superficial lesions with histopathological confirmation of malignancy will be treated using DaRT seeds. 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). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04906070
Study type Interventional
Source Hekabio
Contact
Status Completed
Phase N/A
Start date May 25, 2019
Completion date May 27, 2022
View Details
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