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

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ClinicalTrials.gov Identifier: NCT01434797
Recruitment Status : Recruiting
First Posted : September 15, 2011
Last Update Posted : November 15, 2016
Sponsor:
Information provided by (Responsible Party):
John O. Prior, University of Lausanne Hospitals

Study Description
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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.

Condition or disease
Infection

Detailed Description:
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.

Study Design
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Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Prospective Study on the Usefulness and Diagnostic Value of F-18-FDG PET/CT in the Diagnosis of Permanent Central Venous Catheters Infection
Study Start Date : September 2011
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : January 2018
Groups and Cohorts
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort
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)


Outcome Measures
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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 ]
    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])


Secondary Outcome Measures :
  1. Diagnostic value (sensitivity and sensibility, positive/negative predictive value) of microcalorimetry in the detection of CVCP infection [ Time Frame: 6 months ]
    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])


Eligibility Criteria
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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.
Criteria

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
Contacts and Locations
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01434797


Contacts
Contact: John O Prior, PhD MD +41 21 314 43 48 john.prior@chuv.ch

Locations
Switzerland
Centre Hospitalier Universitaire Vaudois, Nuclear Medicine Recruiting
Lausanne, Vaud, Switzerland, 1011
Sub-Investigator: François Saucy, MD         
Sub-Investigator: Andrej Trampuz, MD         
Sponsors and Collaborators
University of Lausanne Hospitals
Investigators
Principal Investigator: John O Prior, PhD MD Centre Hospitalier Universitaire Vaudois and University of Lausanne
More Information
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: John O. Prior, Centre Hospitalier Universitaire Vaudois, Nuclear Medicine, University of Lausanne Hospitals
ClinicalTrials.gov Identifier: NCT01434797     History of Changes
Other Study ID Numbers: 89/11
First Posted: September 15, 2011    Key Record Dates
Last Update Posted: November 15, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by John O. Prior, University of Lausanne Hospitals:
Infection
Permanent central venous catheter
Device Related

Additional relevant MeSH terms:
Infection
Communicable Diseases