Ignite Creation Date:
2025-12-24 @ 2:16 PM
Ignite Modification Date:
2026-01-02 @ 2:19 AM
Study NCT ID:
NCT07029295
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-06-19
First Post:
2025-05-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Impact of a Patient Education Protocol on the Quality of 18F-FDG PET Imaging Indicated for Investigation of Cardiac Inflammation
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Study Overview
Official Title:
Evaluation of the Impact of a Patient Education Protocol on the Quality of 18F-FDG PET Imaging Indicated for Investigation of Cardiac Inflammation
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CARTEP
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.
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.
Detailed Description:
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: