NCT04892667Active, not recruiting

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

Source: ClinicalTrials.gov · Last updated 13 Aug 2025

Brief summary (registry, in English)

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.

Status (registry): Active, not recruiting
Study type: Interventional
Enrollment: 128 (actual)
First submitted: 13 Apr 2021
Start date: 1 Apr 2022
Primary completion date: 17 Mar 2026
Lead sponsor: Assistance Publique - Hôpitaux de Paris
NCT number: NCT04892667

What you commit to

Study type: Interventional
Participants enrolled: 128
From 1 Apr 2022 to the primary completion date, 17 Mar 2026
1 site in 1 country
Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

Myocardial infarction in the 3 months prior to inclusion
Heart failure in the 3 months prior to inclusion

Other illness

Cardiological symptomatic patient (Dyspnea, angina, palpitations, syncope, left ventricular insufficiency, right ventricular insufficiency, overall heart failure)
Hypersensitivity to 18F-FDG

Other

FEVG\<53%
Patient for whom PET/CT invalidates the presence of lymphoma (Hodgkin's or non-Hodgkin's)Uncontrolled blood pressure (AP) (systolic AP \> 140 mm Hg and/or diastolic AP \> 90 mmHg)
Severe symptomatic or asymptomatic mitral valvulopathy
Symptomatic or asymptomatic tight aortic stenosis
Atrial Fibrillation
Pregnant or lactating woman
Patient under guardianship or curatorship
Patient under State Medical Aid

Who the study is looking for

Patients of at least 18 years of age, treated as part of an initial extension assessment (staging) of a lymphoma (Hodgkin's or non-Hodgkin's)
Treatment with a chemotherapy protocol containing Anthracyclines (ABVD protocol, enhanced BEACOPP, R CHOP, CHOP, CHOEP, EPOCH, ACVBP)
Signed informed consent
Affiliation to a social security system (AME excepted)

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

Site	City	Country	Site status
Cardiology department Coordinator of this site? Confirm its status	Paris	France	Unknown status

This page is information, not medical advice. Discuss any trial with your doctor.