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Starting soon Not applicable

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

NCT07029295 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2025-07-01
Last updated
2025-06-19

Condition(s) studied

Infective EndocarditisCardiac Sarcoidosis

Investigational drug(s) / intervention(s)

Sending a link to the videoCompliance questionnaireDetermination of beta-hydroxybutyrate (BHB) in capillary blood

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.

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

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

Study summary

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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • 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. — After the imaging (approximately 1 month after the appointment is scheduled for the imaging)
    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.

Trial sites (2)

FacilityCityRegionStatus
Hôpital Cochin - AP-HP, Service de médecine nucléaire Paris France
Hôpital Européen Georges Pompidou - AP-HP, Service de médecine nucléaire Paris France
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07029295 on ClinicalTrials.gov ↗ ← All trials in France