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

Lymphoma, Non-Hodgkin Clinical Trial

— DETECT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04892667
• Other study ID #: APHP191102
• Secondary ID: IDRCB 2020-A0197
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2022
• Est. completion date: October 2024

Study information

• Verified date: November 2022
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Stephane EDERHY, Dr
• Phone: 01 49 28 25 03
• Email: stephane.ederhy[@]aphp.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 (D42). 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 (D42) should verify a population at risk of developing LVSD at 1 year.

Description:

This is a study that evaluates the sensitivity of the cardiac uptake of 18F-FDG measured on D42 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 multicentre clinical trial with 11 sites participating in the study.

Sample size : 484 patients

Duration of inclusion: 25 months Patient observation period: 12 months Total duration: 37 months

Assessment :

There is an inclusion visit, then protocol visits at D42, 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 484
• Est. completion date: October 2024
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiotoxicity
• Hodgkin Disease
• Lymphoma
• Lymphoma, Hodgkin
• Lymphoma, Non-Hodgkin

Intervention

Other:
• intervention
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.

Locations

Country	Name	City	State
France	Cardiology department	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 42
Secondary	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	SLG change is defined as: difference in SLG measured prior to chemotherapy administration and at the end of chemotherapy (Day 84 or Day 126 depending on the chemotherapy protocol) .	Day 84 and Day 126
Secondary	Compare PET/CT sensitivities at Day 42 and SLG variation between the start and the end of chemotherapy administration (Day 84 or Day 126 depending on the chemotherapy protocol) to identify patients at risk of LVSD at 1 year.		Day 42
Secondary	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
Secondary	Evaluate the concordance between the result of the 18F-FDG cardiac uptake performed at Day 42 assessed by the investigator and the result obtained at the centralized review.		Day 42