Evaluation of the Impact of a Patient Education Protocol on the Quality of 18F-FDG PET Imaging Indicated for Investigation of Cardiac Inflammation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

138 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-01

Study Completion Date

2027-08-31

Brief Summary

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The aim of this study is to assess the impact of implementing a patient education and preparation protocol for FDG PET (18F-FDG PET) imaging on the quality of imaging results.

18F-FDG (18Fluor-FluoroDesoxyGlucose) PET (Positron Emission Tomography) is indicated for the diagnosis of cardiac inflammation. To detect cardiac inflammation, the myocardium (heart muscle) must be prevented from absorbing glucose from the diet (FDG). To achieve this, patient preparation is essential. Poor preparation can compromise the interpretation of results, causing diagnostic delay.

To answer the research question, the investigators plan to include 138 people with suspected infective endocarditis or cardiac sarcoidosis, in two institutions of the Assistance Publique - Hôpitaux de Paris: Hôpital Européen Georges Pompidou and Hôpital Cochin-Port-Royal, located respectively at 20 rue Leblanc 75015 Paris and 27 rue du Faubourg Saint-Jacques 75014 Paris.

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Detailed Description

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18F-FDG (18Fluor-FluoroDesoxyGlucose) PET (Positron Emission Tomography) is indicated for the diagnosis of infective endocarditis or cardiac sarcoidosis. Detection of cardiac inflammation requires suppression of physiological glucose (FDG) uptake in the myocardium. To achieve this, patient preparation (ketogenic diet and fasting) is essential. Failure rates vary from center to center. Poor preparation can compromise interpretation, causing diagnostic delay, additional exposure to ionizing radiation and cost. Interpretation of the examination requires suppressing FDG uptake in the myocardium in order to identify FDG uptake in activated inflammatory cells. With this study, the investigators hope to demonstrate that an intervention upstream of the examination will increase the success rate of the 18F-FDG PET examination indicated for cardiac sarcoidosis or infective endocarditis. This will make it possible to avoid reprogramming the examination in the event of failure, and thus limit the patient's additional exposure to ionizing radiation (radiation protection), and avoid a loss of chance for the patient as well as additional costs for health insurance.

Main objective: To evaluate the benefit of implementing a patient education protocol prior to myocardial 18F-FDG PET on the removal of residual myocardial fixation compared with the usual procedure of sending instructions.

Primary endpoint: Success rate of suppression of residual myocardial FDG uptake. Success criteria according to 4 grades. Grade 1 (no residual FDG fixation), grade 2 (moderate FDG fixation in basal LV segments), grade 3 (residual FDG fixation interfering with interpretation) or grade 4 (diffuse and intense FDG fixation). Grades 1 and 2 define success.

Secondary objectives: By comparing the control group (usual procedure) with the intervention group (new procedure):

A - Evaluate the value of determining ketone bodies in capillary blood before the 18F-FDG PET examination indicated for infectious endocarditis or cardiac sarcoidosis, to predict its success.

B - Evaluate whether the patient education protocol leads to greater compliance with dietary instructions prior to the 18F-FDG PET scan.

C - Investigate whether certain drug excipients are likely to influence the results of the 18F-FDG PET scan, by retrieving the list of drugs taken by the patient 24 hours prior to the scan. Indeed, some excipients may contain fast sugars and this could, perhaps, independently of compliance with dietary instructions, lead to failure of the 18F-FDG PET scan.

Secondary endpoints:

A - Measurement of ketone bodies (BHB) on a capillary blood sample taken just before the examination.

B - Use of a questionnaire (cf. appendix 2) drawn up and distributed by the radio handlers to the patient on arrival in the department on the day of the examination.

C - Collection of medications taken by the patient in the 24 hours preceding the examination.

Conditions

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Infective Endocarditis Cardiac Sarcoidosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized controlled trial in two parallel groups:

* Control group: standard procedure (transmission of instructions sent by e-mail) + compliance questionnaire to be completed on arrival in the day of imaging + BHB (Beta-hydroxybutyrate) assay on capillary blood before imaging.
* Intervention group: standard procedure accompanied by a link to the educational video (3 min, 34 sec.) prepared as part of the study, explaining the importance of proper preparation and the diet to follow + compliance questionnaire to be completed on arrival in the day of imaging + BHB assay on capillary blood prior to imaging.

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Control group

standard procedure (transmission of an instructions sent by e-mail) + compliance questionnaire to be completed on arrival in the day of imaging + BHB assay on capillary blood before imaging.

Group Type ACTIVE_COMPARATOR

Compliance questionnaire

Intervention Type BEHAVIORAL

Patient completes a questionnaire on compliance with preparation instructions on the day of the imaging test.

Determination of beta-hydroxybutyrate (BHB) in capillary blood

Intervention Type BIOLOGICAL

Determination of beta-hydroxybutyrate (BHB) in capillary blood prior to imaging examination.

Intervention group

standard procedure accompanied by a link to the educational video (3 min, 34 sec.) prepared as part of the study, explaining the importance of proper preparation and the diet to follow + compliance questionnaire to be completed on arrival in the day of imaging + BHB assay on capillary blood prior to imaging.

Group Type EXPERIMENTAL

Sending a link to the video

Intervention Type OTHER

Sending a link to the educational video (3 min, 34 sec.) prepared as part of the study, explaining the importance of proper preparation and the diet to follow.

Compliance questionnaire

Intervention Type BEHAVIORAL

Patient completes a questionnaire on compliance with preparation instructions on the day of the imaging test.

Determination of beta-hydroxybutyrate (BHB) in capillary blood

Intervention Type BIOLOGICAL

Determination of beta-hydroxybutyrate (BHB) in capillary blood prior to imaging examination.

Interventions

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Sending a link to the video

Sending a link to the educational video (3 min, 34 sec.) prepared as part of the study, explaining the importance of proper preparation and the diet to follow.

Intervention Type OTHER

Compliance questionnaire

Patient completes a questionnaire on compliance with preparation instructions on the day of the imaging test.

Intervention Type BEHAVIORAL

Determination of beta-hydroxybutyrate (BHB) in capillary blood

Determination of beta-hydroxybutyrate (BHB) in capillary blood prior to imaging examination.

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Presence of a prescription validated by the nuclear medicine department for an 18F-FDG PET scan for the detection of inflammation of cardiac inflammation or infection
* Age greater than or equal to 18
* Membership of a social security scheme or equivalent
* Patients with an e-mail address
* Patients who understand French
* Collection of patient consent

Exclusion Criteria

* Pregnancy or breast-feeding
* Patients (inpatients or outpatients) already on a diet (including ketogenic)
* Patients who do not understand protocol
* Patients deprived of liberty by judicial or administrative decision
* Patients under legal protection (guardianship/trusteeship)
* Patients under court protection

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No