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

Assistance Publique - Hôpitaux de Paris

Status

Active, not recruiting

Conditions

Lymphoma, Hodgkin

Lymphoma, Non-Hodgkin

Treatments

Other: Intervention

Study type

Interventional

Funder types

Other

Identifiers

NCT04892667

IDRCB 2020-A01971-38 (Other Identifier)

APHP191102

Details and patient eligibility

About

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.

Full description

This is a study that evaluates 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%.

Design : A multicenter clinical trial with 11 sites participating in the study.

Sample size : 484 patients

Duration of inclusion: 37 months Patient observation period: 12 months Total duration: 49 months

Assessment :

There is an inclusion visit, then protocol visits at D28 +/- 7 days, D42 +/- 7 days ou D56 + 4 days, 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.

Enrollment

128 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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)

Exclusion criteria

FEVG<53%
Cardiological symptomatic patient (Dyspnea, angina, palpitations, syncope, left ventricular insufficiency, right ventricular insufficiency, overall heart failure)
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)
Myocardial infarction in the 3 months prior to inclusion
Heart failure in the 3 months prior to inclusion
Severe symptomatic or asymptomatic mitral valvulopathy
Symptomatic or asymptomatic tight aortic stenosis
Atrial Fibrillation
Pregnant or lactating woman
Hypersensitivity to 18F-FDG
Patient under guardianship or curatorship
Patient under State Medical Aid