Early Detection of Patients at Risk of Developing Anthracycline Cardiotoxicity With TEP/CT -FDG (DETECT)
Primary Purpose
Lymphoma, Non-Hodgkin, Lymphoma, Hodgkin
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
intervention
Sponsored by
About this trial
This is an interventional prevention trial for Lymphoma, Non-Hodgkin focused on measuring Lymphoma, Anthracyclines, Cardiac toxicity, Chemotherapy, Left Ventricular Systolic Dysfunction (LVSD), 18F-FDG, Echocardiography, PET-CT, Strain longitudinal global (SLG)
Eligibility Criteria
Inclusion Criteria:
- Patient with at least 18 years of age, treated for lymphoma (Hodgkin or non-Hodgkin)
- 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)
- 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
Sites / Locations
- Cardiology departmentRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Patients with lymphoma (Hodgkin's or non Hodgkin's)
Arm Description
Outcomes
Primary Outcome Measures
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%.
Secondary Outcome Measures
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) .
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.
Search for an intensity threshold in Standard Uptake Value (SUV)) of global 18F-FDG uptake to predict the occurrence of LVSD at 1 year.
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.
Full Information
NCT ID
NCT04892667
First Posted
April 13, 2021
Last Updated
November 21, 2022
Sponsor
Assistance Publique - Hôpitaux de Paris
1. Study Identification
Unique Protocol Identification Number
NCT04892667
Brief Title
Early Detection of Patients at Risk of Developing Anthracycline Cardiotoxicity With TEP/CT -FDG
Acronym
DETECT
Official Title
Early Detection of Patients at Risk of Developing Anthracycline Cardiotoxicity With TEP/CT -FDG
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2022 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
October 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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 (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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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)
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
484 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patients with lymphoma (Hodgkin's or non Hodgkin's)
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Evaluation of the cardiac uptake of 18F-FDG
Description
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%.
Time Frame
Day 42
Secondary Outcome Measure Information:
Title
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
Description
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) .
Time Frame
Day 84 and Day 126
Title
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.
Time Frame
Day 42
Title
Search for an intensity threshold in Standard Uptake Value (SUV)) of global 18F-FDG uptake to predict the occurrence of LVSD at 1 year.
Time Frame
1 year
Title
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.
Time Frame
Day 42
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stephane EDERHY, Dr
Phone
01 49 28 25 03
Email
stephane.ederhy@aphp.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Ariel COHEN, PR
Phone
01 49 28 28 66
Email
ariel.cohen@aphp.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephane EDERHY
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cardiology department
City
Paris
ZIP/Postal Code
75012
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephane EDERHY
Phone
01 49 28 25 03
12. IPD Sharing Statement
Learn more about this trial
Early Detection of Patients at Risk of Developing Anthracycline Cardiotoxicity With TEP/CT -FDG
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