A unique approach for cancer treatment employing intratumoral diffusing alpha radiation emitter device for Malignant Cutaneous Tumors
This will be a prospective, open label, single arm, multi- center study, assessing the safety and effectiveness 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. Cutaneous lesions with histopathological confirmation of malignancy will be treated using DaRT seeds. Reduction in tumor size 9-11 weeks following DaRT insertion will be assessed. Safety will be assessed by the frequency, severity and causality of all Adverse Events (AE).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
80
Seed(s) loaded with Radium-224 for local intratumoral irradiation with the destructive power of alpha particles
CHU Grenoble Alpes
Grenoble, France
RECRUITINGCentre Léon Bérard
Lyon, France
RECRUITINGThe objective response rate to DaRT treatment
Assessment of tumor response rate using the Response Evaluation Criteria in Solid Tumors (RECIST) (Version 1.1)
Time frame: up to 9-11 weeks
Tumor volume
Assessment of the reduction in tumor volume based on imaging tests
Time frame: up to 9-11 weeks
DaRT seeds placement
Assessment of the DaRT seed placement by localization of the DaRT seed in the tumor using CT imaging
Time frame: Day of DaRT insertion procedure
Change in quality of life as assessed by the Skindex-16 questionnaire
Assessment of patient reported health-related Quality of Life (QoL) outcomes using the Skindex-16 questionnaire
Time frame: up to 9-11 weeks
Disease-Free Survival (DFS) rate
Assessment of Disease-Free Survival
Time frame: up to 24 months
Change in quality of life as assessed by the Skin Cancer Index (SCI) questionnaire
Assessment of patient reported health-related Quality of Life (QoL) outcomes using the Skin Cancer Index (SCI) questionnaire.
Time frame: up to 9-11 weeks
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