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

NCT04892667 | Active Not Recruiting

• 2 other identifiers: APHP191102IDRCB 2020-A01971-38
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Lymphoma; Anthracyclines; Cardiac toxicity; Chemotherapy; Left Ventricular Systolic Dysfunction (LVSD); 18F-FDG; Echocardiography; PET-CT; Strain longitudinal global (SLG)

Outcome Measures

Primary Outcomes (1)

• Evaluation of the cardiac uptake of 18F-FDG

  Evaluation of the cardiac uptake of 18F-FDG measured on Day 42 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%.

  Day 28 +/- 7 days, Day 42 +/- 7 days or Day 56 + 4 days

Secondary Outcomes (5)

• The specificity, the negative predictive value and the positive predictive value of 18F-FDG cardiac uptake

  Day 28 +/- 7 days, Day 42 +/- 7 days or Day 56 + 4 days

• Evaluate with the echocardiography performed at the end of chemotherapy the sensitivity, specificity, the negative predictive value and the positive predictive value of the SLG change (difference of

  Day 84 and Day 126

• Compare PET/CT sensitivities at D28 +/- 7 days, D42 +/- 7 days or D56 + 4 days and SLG variation between the start and the end of chemotherapy administration (D84 or D126 depending on the chemotherapy protocol) to identify patients at risk of LVSD at 1 y

  Day 28 +/- 7 days, Day 42 +/- 7 days or Day 56 + 4 days

• Search for an intensity threshold in Standard Uptake Value (SUV)) of global 18F-FDG uptake to predict the occurrence of LVSD at 1 year.

  1 year

• Evaluate the concordance between the result of the 18F-FDG cardiac uptake performed at D28 +/- 7 days, D42 +/- 7 days or D56 + 4 days assessed by the investigator and the result obtained at the centralized review.

  Day 28 +/- 7 days, Day 42 +/- 7 days or Day 56 + 4 days

Study Arms (1)

Patients with lymphoma (Hodgkin's or non Hodgkin's)

OTHER

Other: Intervention

Interventions

Intervention OTHER

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.

Patients with lymphoma (Hodgkin's or non Hodgkin's)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Cardiology department

Paris, 75012, France

Location

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin; Hodgkin Disease; Lymphoma; Cardiotoxicity; Ventricular Dysfunction, Left

Interventions

Methods

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders; Radiation Injuries; Wounds and Injuries; Ventricular Dysfunction

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Stephane EDERHY

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2021
• First Posted: May 19, 2021
• Study Start: April 1, 2022
• Primary Completion: March 17, 2026
• Study Completion: March 17, 2026
• Last Updated: August 13, 2025

Record last verified: 2025-08

Locations

FR (1)