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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAssistance Publique - Hôpitaux de Paris

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Sending a link to the video

    Other intervention

    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

    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

    Biological/Vaccine

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

Treatment groups

138 Participants
are divided into 2 treatment groups
Group A: Control groupActive comparator 2 interventions
Group B: Intervention groupExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Evaluate the benefit of implementing a patient education protocol prior to myocardial 18F-FDG PET on the removal of residual myocardial fixation compared to the usual procedure of sending instructions.

Interpretation of imaging results : Success rate of suppression of residual myocardial FDG uptake. Success criteria according to 4 grades. Grade 1 (no residual FDG uptake), grade 2 (moderate FDG uptake in basal LV segments), grade 3 (residual FDG fixation interfering with interpretation) or grade 4 (diffuse, intense FDG uptake). Grades 1 and 2 define success. Centralized review by two independent nuclear medicine physicians and definition of residual FDG uptake in the myocardium blinded to the inclusion group. If there was a discrepancy between the scores, rereading by a 3rd nuclear physician.

Time frame
After the imaging (approximately 1 month after the appointment is scheduled for the imaging)

Secondary outcomes

1

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

Measurement of ketone bodies (BHB) on a capillary blood sample just before the imaging.

Time frame
Before the imaging (approximately 1 month after the appointment is scheduled for the imaging)
2

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

Use of a questionnaire prepared and distributed by radio operators to the patient on arrival on the day of the imaging.

Time frame
Before the imaging (approximately 1 month after the appointment is scheduled for the imaging)
3

Investigate whether certain drug excipients are likely to influence PET-18F-FDG results

Collection of medications taken by the patient in the 24 hours preceding the imaging.

Time frame
Before the imaging (approximately 1 month after the appointment is scheduled for the imaging)

Other outcomes

Sponsors and contacts

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