Alpha Radiation Emitters Device for the Treatment of of Malignant Cutaneous Tumors
Last updated on July 2021Recruitment
- 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