Detecting heart risks in lymphoma patients receiving anthracycline chemotherapy
Early Detection of Patients At Risk of Developing Anthracycline Cardiotoxicity with TEP/CT -FDG
This study is testing if a special imaging technique can help find lymphoma patients at risk of heart problems after they receive anthracycline chemotherapy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 484 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Paris) |
| Trial ID | NCT04892667 on ClinicalTrials.gov |
What this trial studies
This study aims to identify patients at risk of developing Left Ventricular Systolic Dysfunction (LVSD) after receiving anthracycline chemotherapy for lymphoma. It evaluates the sensitivity of cardiac uptake of 18F-FDG at various time points following treatment to predict LVSD, defined as a significant drop in left ventricular ejection fraction (LVEF). The study involves 484 patients across 11 sites and includes multiple assessments over a 12-month observation period. The goal is to improve early detection and management of cardiac toxicity in these patients.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who are undergoing chemotherapy protocols containing anthracyclines for lymphoma.
Not a fit: Patients with existing significant cardiac issues or those with a left ventricular ejection fraction below 53% will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to earlier identification and monitoring of patients at risk for heart complications, potentially improving their long-term health outcomes.
How similar studies have performed: Other studies have explored similar early detection strategies for cardiac toxicity, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Paris
- Cardiology department — Paris, France (Recruiting)
Study contacts
- Principal investigator: Stephane EDERHY — Assistance Publique - Hôpitaux de Paris
- Study coordinator: Stephane EDERHY, Dr
- Email: stephane.ederhy@aphp.fr
- Phone: 01 49 28 25 03
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.