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

NCT04892667 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 128

Last updated 2025-08-13

No results posted yet for this study

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 (D28 +/- 7 days, D42 +/- 7 days ou D56 + 4 days). 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 (D28 +/- 7 days, D42 +/- 7 days ou D56 + 4 days) should verify a population at risk of developing LVSD at 1 year.

Conditions

  • Lymphoma, Non-Hodgkin
  • Lymphoma, Hodgkin

Interventions

OTHER

Intervention

Evaluation of the sensitivity of the cardiac uptake of 18F-FDG measured on D28 +/- 7 days, D42 +/- 7 days ou D56 + 4 days 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%. The patient participating in the study needs to respect a minimum of 12-hour fasting period, a high protein and a low-carbohydrate diet prior to performing PET/CT in order to limit physiological 18F-FDG myocardial fixation.

Sponsors & Collaborators

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Stephane EDERHY · Assistance Publique - Hôpitaux de Paris

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-01
Primary Completion
2026-03-17
Completion
2026-03-17

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04892667 on ClinicalTrials.gov