Recruitment

Recruitment Status
Not yet recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Cutaneous Metastasis
  • Cutaneous Tumor
  • Skin Cancer
Type
Interventional
Phase
Not Applicable
Design
Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Description

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...

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).

Tracking Information

NCT #
NCT04068155
Collaborators
Not Provided
Investigators
Principal Investigator: Dr Pascal POMMIER Centre Leon Berard Principal Investigator: Pr Jean Michel HANNOUN LEVI Antoine Lacassagne Cancer Center Principal Investigator: Pr Jean Marc COSSET Amethyst (Garenne-Colombes) Principal Investigator: Dr Pierre BLANCHARD Gustave Roussy, Cancer Campus, Grand Paris Principal Investigator: Dr Anne DUCASSOU Institut Universitaire du Cancer Toulouse - Oncopole Principal Investigator: Dr Sophie RENARD Institut de Cancérologie de Lorraine, Nancy Principal Investigator: Dr Camille VERRY University Hospital, Grenoble Principal Investigator: Dr Alain TOLEDANO Institut de Cancérologie Hartmann