Early Detection of Patients at Risk of Developing Anthracycline Cardiotoxicity With TEP/CT -FDG — DETECT  

Lymphoma, Non-Hodgkin Clinical Trial

Official title: Early Detection of Patients at Risk of Developing Anthracycline Cardiotoxicity With TEP/CT -FDG

Status Recruiting

Clinical Trial Summary

Management of patients with lymphoma is based on the administration of a chemotherapy containing anthracyclines (ATC), and allows cure rates of 65% to 80% at 5 years. The administration of ATCs can lead to an increase in the risk of the Left Ventricular Systolic dysfunction (LVSD) which ranges from 6 to 15% at 1 year, and of heart failure from which impact at 3.5 years can reach 5%. The major issue in the management of this toxicity is the early identification of this population for monitoring and prevention. No pharmacological intervention strategy is currently recommended.

According to the recommendations of the European Society of Cardiology, this identification is based on the measurement of the left ventricular ejection fraction (LVEF) and the overall longitudinal strain (SLG) before and after the last administration of ATC ( at D84 or D126, depending on the duration of the chemotherapy protocol). Recent studies have evaluated the diagnostic performance of earlier strategies highlighting the benefit of SLG measured after 150 mg / m2 of ATC (D42). However, the tools are lacking to detect these patients as close as possible to the onset of ATC, a necessary condition for effective secondary prevention. The hypothesis is that an early assessment of myocardial binding of 18F-FDG, analyzed during the first routine PET / CT scan as part of the assessment of the response to chemotherapy (D42) should verify a population at risk of developing LVSD at 1 year.

Clinical Trial 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 LVSD 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. ;

Related Conditions & MeSH terms

• Cardiotoxicity
• Hodgkin Disease
• Lymphoma
• Lymphoma, Hodgkin
• Lymphoma, Non-Hodgkin

• NCT number: NCT04892667
• Study type: Interventional
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Stephane EDERHY, Dr
• Phone: 01 49 28 25 03
• Email: stephane.ederhy@aphp.fr
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2022
• Completion date: October 2024