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Lymphoma, Non-HodgkinDETECTNCT04892667

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

A study testing Intervention in people with Lymphoma, Non-Hodgkin and Lymphoma, Hodgkin, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lymphoma, Non-Hodgkin, Lymphoma, Hodgkin
What is being tested?
Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
128 participants
Where
1 siteFrance
Study dates
1 Apr 2022to 17 Mar 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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
Show all 12Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

France1 site

  • Cardiology department

    Paris, 75012

Other trials in France

About this study

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.

Read the detailed 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 \&lt;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.

Being tested
Intervention
Keywords
Lymphoma, Anthracyclines, Cardiac toxicity, Chemotherapy, Left Ventricular Systolic Dysfunction (LVSD), 18F-FDG, Echocardiography, PET-CT, Strain longitudinal global (SLG)
Medical subject headings
Lymphoma, Non-Hodgkin, Hodgkin Disease, Lymphoma, Cardiotoxicity, Ventricular Dysfunction, Left

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • InterventionOther

    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 \&lt; 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.

Study groups in NCT04892667
Study groupRoleWhat they receive
Patients with lymphoma (Hodgkin's or non Hodgkin's)OtherNot described
Receives: Other: Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  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 \&lt;53%.

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

Secondary outcomes (5)

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

    Evaluate the specificity, the negative predictive value and the positive predictive value of 18F-FDG cardiac uptake of ATC administration to identify patients at risk of developing LVSD at 1 year (defined by a decrease of more than 10 units of LVEF and LVEF \&amp;amp;amp;amp;amp;amp;amp;amp;lt; 53%).

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

  2. 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) .

    Measured: Day 84 and Day 126

  3. 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

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

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

    Measured: 1 year

  5. 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 May 2021
  2. Study start1 Apr 2022
  3. Primary completion17 Mar 2026 (estimated)
  4. Study completion17 Mar 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
128 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04892667
Sponsor's protocol ID
APHP191102
Other IDs
IDRCB 2020-A01971-38
Acronym
DETECT
Status last verified
Aug 2025
First submitted
13 Apr 2021
Last updated
13 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Intervention in people with Lymphoma, Non-Hodgkin and Lymphoma, Hodgkin, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 13 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evaluation of the cardiac uptake of 18F-FDG (time frame: Day 28 +/- 7 days, Day 42 +/- 7 days or Day 56 + 4 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04892667.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2025.

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