Impact of FDG-PET/CT on Management of Patients With Native Valve Infective Endocarditis (PET-NAVIE)

The proposed study is a multicentric prospective observational cohort study of patients with suspected NVE. The study population includes those with Possible IE according to the modified Duke criteria and investigated at one of the 6 participating sites which include 2 cardiac centers, the MHI and the IUCPQ, as well as 4 tertiary care centers, the Jewish General Hospital , the McGill University Health Centre and the CHUS.

Study Overview

• Status: Recruiting
• Conditions: Infective Endocarditis; Native Valve Endocarditis

• Study Type: Observational
• Enrollment (Estimated): 97

Contacts and Locations

Study Locations

• Canada
  • Quebec, Canada, G1V 4G5
    • Not yet recruiting
    • University Institute of Cardiology and Respirology of Quebec
    • Contact: Jean-Francois Sarrazin
  • Quebec
    • Montreal, Quebec, Canada, H3T 1E2
      • Recruiting
      • Jewish General Hospital
      • Contact: Gad Abikhzer; Phone Number: 514-340-8222; Email: gad101@hotmail.com
    • Montreal, Quebec, Canada, H4A 3J1
      • Not yet recruiting
      • McGill University Health Center
      • Contact: Anthony Ciarallo; Phone Number: 514-934-1934; Email: Anthony.Ciarallo.med@ssss.gouv.qc.ca
    • Montréal, Quebec, Canada, H2X 3E4
      • Not yet recruiting
      • Centre Hospitalier de l'Universite de Montreal
      • Contact: Daniel Juneau
    • Montréal, Quebec, Canada, H3l 3c1
      • Recruiting
      • Montreal Heart Institute
      • Contact: Matthieu Pelletier-Galarneau; Phone Number: 4418 5143763330; Email: matthieu.pelletier-galarneau@icm-mhi.org
    • Sherbrooke, Quebec, Canada, J1H5H3
      • Not yet recruiting
      • Centre Hospitalier de l'Université de Sherbrooke
      • Contact: Etienne Rousseau

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

The study population includes those with Possible IE according to the modified Duke criteria and investigated at one of the 5 participating sites

Description

Inclusion Criteria:

• 18 years of age or older, capable to provide informed consent;
• Referred for a FDG-PET/CT study
• Classified as having Possible IE prior to FDG-PET/CT imaging;
• Patients must be able to tolerate the physical/logistical requirements of a PET/CT scan.

Exclusion Criteria:

• Subjects with prosthetic cardiac valve and/or CIED;
• Pregnant or breastfeeding female;
• Body mass index > 45 kg/m2.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Patients with suspected native valve endocarditis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients with Possible IE that will be appropriately reclassified	Proportion of patients with Possible IE that will be appropriately reclassified as Definite IE by the addition of FDG-PET to the Duke criteria.	3 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Sensitivity, specificity, and accuracy of FDG-PET for the detection of NVE	3 months
Sensitivity, specificity, and accuracy of the Duke criteria with FDG-PET for detection of NVESensitivity, specificity, and accuracy of the Duke criteria with FDG-PET for detection of NVE	3 months
Sensitivity, specificity, and accuracy of the Duke criteria with FDG-PET but excluding TEE for the detection of NVE	3 months
Differences in maximal standardized uptake value (SUVmax) between infected and non-infected valves	3 months
Differences target-to-background ratio (TBR) between infected and non-infected valves	3 months
Proportion of patients in whom a TEE was not necessary to diagnose NVE through the addition of FDG-PET	3 months
Proportion of patients with final diagnosis of IE with septic emboli detected on whole body FDGPET	3 months
Differences in the rate of sub-optimal suppression protocol between males and females	3 months
Proportion of patients with incidental cancer identified on FDG-PET	3 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation between the diagnostic accuracy and available demographic, technical, and clinical factors	Correlation between the diagnostic accuracy (false-negative/false-positive studies versus truenegative/true-positive) and the available demographic and clinical factors (age, sex, duration of antibiotherapy, blood glucose, CRP, history of renal failure, history of malignancy, history of diabetes, chronic liver disease, time since onset of symptoms, and quality of myocardial suppression) as well as camera system (analog vs digital)	3 months
Difference in the area under the curve (c-statistic) of the Duke criteria with TEE but excluding FDG-PET, with TEE and FDG-PET, and with FDG-PET but excluding TEE		3 months
Differences in sensitivity, specificity, and accuracy of FDG-PET with and without respiratory and ECG-gated acquisitions		3 months

Collaborators and Investigators

• Sponsor: Montreal Heart Institute

Study record dates

Study Major Dates

• Study Start (Actual): August 31, 2021
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: March 5, 2021
• First Submitted That Met QC Criteria: March 9, 2021
• First Posted (Actual): March 10, 2021

Study Record Updates

• Last Update Posted (Actual): October 19, 2023
• Last Update Submitted That Met QC Criteria: October 18, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: PET/CT; FDG; Duke Criteria
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Infections; Bacterial Infections; Bacterial Infections and Mycoses; Cardiovascular Infections; Endocarditis, Bacterial; Endocarditis
• Other Study ID Numbers: MP-33-2020-2674

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No