Diagnostic Accuracy of 18FDG-PET-CT for Pacing or Defibrillation Lead Infection (ENDOTEP)

February 8, 2022 updated by: University Hospital, Bordeaux

Assessment of Diagnostic Accuracy of 18FDG-PET-CT in Patients With Suspicion of Pacing or Defibrillation Lead Infection: a Prospective Multi-center Study

With aging of the general population and broadening indications, the number of pacemaker recipients is steadily increasing. The incidence of infections of the implanted material, a dreaded major complication, is also rising. The diagnosis is evident in presence of an abscessed pocket, cutaneous breakthrough of the pulse generator or vegetations attached to the lead. On the other hand, a proportion of patients present with less specific clinical manifestations and a pacemaker recipient may be recurrently hospitalized for an infectious disorder of unknown origin despite detailed investigations. Without proof of lead infection, removal of the system without confirmation of its infection is usually proposed, despite the known morbidity and mortality associated with the extraction procedure (0.5 to 2%). Positive culture of the leads implies that the leads were involved in the infectious process. In recent years, 18FDG-PET-CT scan has made promising contributions in different areas including imaging to detect infection at different organ sites. Absence of hyperfixation of the lead, identified by 18FDG-PET/CT scan may be an accurate sign of absence of pacing system infection.

The extraction of intracardiac implanted material, when it is indicated by the current standard strategy, may result in negative bacteriological cultures in 10 to 25% of patients, even when they did not receive antibiotics before extraction.

The hypothesis of the study is that a new strategy adding 18FDG-PET-CT to the current strategy may avoid or reduce these false-positives.

Therefore it is hypothesized that the sensitivity of 18FDG-PET-CT will be high enough to avoid unnecessary extractions of uninfected leads, resulting in a high negative predictive value of the new diagnostic strategy incorporating 18FDG-PET-CT. The present study aims at providing valid estimates of diagnostic accuracy parameters of 18FDG-PET-CT, especially its sensitivity.

For this clinical study, firstly, 18FDG-PET-CT exam will be performed in patients, with suspicion of pacing or defibrillation lead infection, hospitalized in cardiology unit; secondarily, an intervention for the extraction of the intra-cardiac material, under general anesthesia, will be practiced and then a bacteriological culture for extracted material will be required.

The end of study visit is complete the last day of material extraction. The follow up will last 2 to 7 days.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

235

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Grenoble, France, 38043
        • CHU de Grenoble - Hôpital A. Michallon
      • Lille, France, 59037
        • CHRU de Lille - Hôpital R. Salengro
      • Marseille, France, 13385
        • AP-HM - Hôpital la Timone
      • Pessac, France, 33604
        • CHU de Bordeaux
      • Toulouse, France, 31076
        • Clinique Pasteur
      • Vandoeuvre Les Nancy, France, 54500
        • CHU de Nancy - Hopital de Brabois

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Both genders
  • Age > 18 years
  • Patient referred for extraction of cardiac material (box and lead(s)) in the context of suspicion of material infection, including a patient with pocket infection.
  • Possibility of carrying out PET-CT no more than 48 hours before extraction (or, exceptionally, no more than 7 days if the patient is not under antibiotic therapy).
  • Informed written consent
  • Affiliation to a social security system

Exclusion Criteria:

  • Pregnant or breastfeeding women
  • Patients with recent implantation (less than 2 months)
  • Subjects placed under judicial protection
  • Subjects participating in another study that includes an exclusion period on-going at the time of screening.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Whole-body 18FDG-PET-CT scan
18FDG-PET-CT exam will be performed in patients, with suspicion of pacing or defibrillation lead infection, hospitalized in cardiology unit.
Device: Whole-body 18FDG-PET-CT scan
18FDG-PET-CT exam will be performed in patients, with suspicion of pacing or defibrillation lead infection, hospitalized in cardiology unit.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
A semi-quantitative visual interpretation of 18FDG-PET-CT in the diagnosis of infection of intracardiac device.
Time Frame: up to 48 hours after inclusion (exceptionally, up to 7 days if the patient is not under antibiotic therapy)

Index tests will be interpreted by nuclear medicine physician from the center where the patient was included with a semi-quantitative visual score.

Moreover, all 18FDG-PET-CT recordings will be sent to the coordinating center for centralized interpretation blind to the preceding one.

All 18FDG-PET-CT recordings will be stored until interpretation, and not used for the clinical management of the patient.

Index test interpretations will be carried out blind to any other information on the patient (clinical, biology,…).
up to 48 hours after inclusion (exceptionally, up to 7 days if the patient is not under antibiotic therapy)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Bordeaux

Investigators

  • Principal Investigator: Pierre Bordachar, MD, University Hospital, Bordeaux
  • Study Chair: Paul PEREZ, MD, PhD, University Hospital, Bordeaux

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 22, 2015

Primary Completion (Actual)

June 19, 2018

Study Completion (Actual)

June 19, 2018

Study Registration Dates

First Submitted

September 24, 2014

First Submitted That Met QC Criteria

September 24, 2014

First Posted (Estimate)

September 29, 2014

Study Record Updates

Last Update Posted (Actual)

February 9, 2022

Last Update Submitted That Met QC Criteria

February 8, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHUBX 2013/31

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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