Early Detection of Patients at Risk of Developing Anthracycline Cardiotoxicity With TEP/CT -FDG
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Lymphoma, Hodgkin
- Lymphoma Non-Hodgkin
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Prevention
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
This is a study that evaluates the sensitivity of the cardiac uptake of 18F-FDG measured on D42 of the administration of ATCs to identify at 1 year the patients at risk of occurrence of a DVSG defined by a drop of more than 10 units of the LVEF and LVEF <53%. Design : A multicentre clinical trial wi...
This is a study that evaluates the sensitivity of the cardiac uptake of 18F-FDG measured on D42 of the administration of ATCs to identify at 1 year the patients at risk of occurrence of a DVSG defined by a drop of more than 10 units of the LVEF and LVEF <53%. Design : A multicentre clinical trial with 11 sites participating in the study. Sample size : 484 patients Duration of inclusion: 25 months Patient observation period: 12 months Total duration: 37 months Assessment : There is an inclusion visit, then protocol visits at D42, D84 or D126 and at the end of the study (M12). There is no interim analysis planned. Analyzes will be performed at the end of the test after reviewing the data and freezing the database.
Tracking Information
- NCT #
- NCT04892667
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Stephane EDEEHY Assistance Publique - Hôpitaux de Paris
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