Value of PET/CT Imaging in the Diagnosis of Permanent Central Venous Catheters Infection

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2016 by University of Lausanne Hospitals
Sponsor:
Information provided by (Responsible Party):
John O. Prior, University of Lausanne Hospitals
ClinicalTrials.gov Identifier:
NCT01434797
First received: September 1, 2011
Last updated: January 24, 2016
Last verified: January 2016

September 1, 2011
January 24, 2016
September 2011
December 2016   (final data collection date for primary outcome measure)
Diagnostic value (sensitivity and sensibility, positive/negative predictive value) of F-18-FDG PET/CT imaging in the detection of CVCP infection [ Time Frame: 6 months ] [ Designated as safety issue: No ]
To determine the clinical use of PET/CT in the detection of catheter infection by comparing PET/CT imaging results to standard means of catheter infection detection (i.e. clinical signs and hemoculture [positive or negative])
Same as current
Complete list of historical versions of study NCT01434797 on ClinicalTrials.gov Archive Site
Diagnostic value (sensitivity and sensibility, positive/negative predictive value) of microcalorimetry in the detection of CVCP infection [ Time Frame: 6 months ] [ Designated as safety issue: No ]
To determine the clinical use of microcalorimetry in the detection of catheter infection by comparing microcalorimetry results to standard means of catheter infection detection (i.e. clinical signs and hemoculture [positive or negative])
Same as current
Not Provided
Not Provided
 
Value of PET/CT Imaging in the Diagnosis of Permanent Central Venous Catheters Infection
Prospective Study on the Usefulness and Diagnostic Value of F-18-FDG PET/CT in the Diagnosis of Permanent Central Venous Catheters Infection
The study hypothesis is that F-18-FDG PET/CT and microcalorimetry might have a diagnostic value in the detection of permanent central venous catheters (PCVC) infection when conventional means of PCVC infection detection are non-conclusive.
Permanent central venous catheters are frequently infected and therefore need surgical removal. When a clear diagnostic for infection cannot be defined, catheter removal might be at risk for the patient, for the therapeutic follow-up and in terms of costs. PET/CT and microcalorimetry might help giving conclusive diagnostic of catheter infection.
Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
Patients with pathology requiring permanent central venous catheter will be selected mainly from nephrology and oncology departments . They might also be selected from other deparments.
Infection
Not Provided
  • Confirmed CVCP infection before removal
    Patients with permanent central venous catheter infection confirmed by conventional method
  • Presumed CPVP infection before removal
    Patients with probable permanent central venous catheter infection (standard methods for infection detection not conclusive)
  • Uninfected CVCP before removal
    Patients with planned permanent central venous catheter removal (no infection)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
40
January 2017
December 2016   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • patients with confirmed catheter infection requiring surgical removal
  • patients with probable catheter infection requiring surgical removal
  • patients with planned removal of uninfected catheter
  • ≥18years old

Exclusion Criteria:

  • extreme claustrophobia
  • pregnancy and breastfeeding
  • severe septicemia
Both
18 Years and older   (Adult, Senior)
No
Contact: John O Prior, PhD MD +41 21 314 43 48 john.prior@chuv.ch
Switzerland
 
NCT01434797
89/11
No
No
Not Provided
John O. Prior, University of Lausanne Hospitals
University of Lausanne Hospitals
Not Provided
Principal Investigator: John O Prior, PhD MD Centre Hospitalier Universitaire Vaudois and University of Lausanne
University of Lausanne Hospitals
January 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP