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

NCT01434797 | Completed

• 1 other identifier: 89/11
• Study Type: observational
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Infection

Keywords

Infection; Permanent central venous catheter; Device Related

Outcome Measures

Primary Outcomes (1)

• Diagnostic value (sensitivity and sensibility, positive/negative predictive value) of F-18-FDG PET/CT imaging in the detection of CVCP infection

  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 \[positive or negative\])

  6 months

Secondary Outcomes (1)

• Diagnostic value (sensitivity and sensibility, positive/negative predictive value) of microcalorimetry in the detection of CVCP infection

  6 months

Study Arms (3)

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)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• extreme claustrophobia
• pregnancy and breastfeeding
• severe septicemia

Sponsors & Collaborators

• University of Lausanne Hospitals: lead

Study Sites (1)

Centre Hospitalier Universitaire Vaudois, Nuclear Medicine

Lausanne, Canton of Vaud, 1011, Switzerland

Location

MeSH Terms

Conditions

Infections

Study Officials

• John O Prior, PhD MD

  Centre Hospitalier Universitaire Vaudois and University of Lausanne

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Centre Hospitalier Universitaire Vaudois, Nuclear Medicine

Study Record Dates

• First Submitted: September 1, 2011
• First Posted: September 15, 2011
• Study Start: September 1, 2011
• Primary Completion: November 1, 2014
• Study Completion: March 1, 2020
• Last Updated: March 31, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)