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

NCT07029295 | Not Yet Recruiting

• 3 other identifiers: APHP2503432025-A00410-4925.00839.000457
• Study Type: interventional
• Target: 138
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Infective Endocarditis; Cardiac Sarcoidosis

Keywords

18F-FDG; PET; infective endocarditis; cardiac sarcoidosis; patient preparation; patient education protocol

Outcome Measures

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.

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

Secondary Outcomes (3)

• 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

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

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

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

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

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

Study Arms (2)

Control group

ACTIVE COMPARATOR

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.

Behavioral: Compliance questionnaire; Biological: Determination of beta-hydroxybutyrate (BHB) in capillary blood

Intervention group

EXPERIMENTAL

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.

Other: Sending a link to the video; Behavioral: Compliance questionnaire; Biological: Determination of beta-hydroxybutyrate (BHB) in capillary blood

Interventions

Sending a link to the video 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.

Intervention group

Compliance questionnaire BEHAVIORAL

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

Control group; Intervention group

Determination of beta-hydroxybutyrate (BHB) in capillary blood BIOLOGICAL

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

Control group; Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (2)

Hôpital Cochin - AP-HP, Service de médecine nucléaire

Paris, France

Location

Hôpital Européen Georges Pompidou - AP-HP, Service de médecine nucléaire

Paris, France

Location

MeSH Terms

Conditions

Endocarditis

Interventions

3-Hydroxybutyric Acid

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Hydroxybutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Ketone Bodies; Ketones; Fatty Acids, Volatile; Fatty Acids; Lipids

Study Officials

• Julien HO

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Youcef SEKOUR

CONTACT

+33156095823; youcef.sekour@aphp.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 27, 2025
• First Posted: June 19, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): August 31, 2027
• Last Updated: June 19, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Two years after the last publication
• Access Criteria: Data sharing must be accepted by the sponsor and the PI based on a scientific project and scientific involvement of the PI team. Collaboration will be fostered. Teams wishing obtain IPD must meet the sponsor and IP team to present scientifics (and commercial) purpose, IPD needed, format of data transmission, and timeframe. Technical feasibility and financial support will be discussed before mandatory contractualization. Processing of shared data must comply with European General Data Protection Regulation (GDPR).

Locations

FR (2)