Value of PET/CT Imaging in the Diagnosis of Permanent Central Venous Catheters Infection
This study is currently recruiting participants.
Verified April 2012 by University of Lausanne Hospitals
Sponsor:
University of Lausanne Hospitals
Information provided by (Responsible Party):
John O. Prior, University of Lausanne Hospitals
ClinicalTrials.gov Identifier:
NCT01434797
First received: September 1, 2011
Last updated: April 16, 2012
Last verified: April 2012
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Purpose
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 |
|---|
|
Infection |
| Study Type: | Observational |
| Study Design: | 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 |
Further study details as provided by University of Lausanne Hospitals:
Primary Outcome Measures:
- 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])
Secondary Outcome Measures:
- 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])
| Estimated Enrollment: | 40 |
| Study Start Date: | September 2011 |
| Estimated Study Completion Date: | February 2013 |
| Groups/Cohorts |
|---|
|
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)
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: 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
No publications provided
| 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 |
| Study First Received: | September 1, 2011 |
| Last Updated: | April 16, 2012 |
| Health Authority: | Switzerland: Ethikkommission |
Keywords provided by University of Lausanne Hospitals:
|
Infection Permanent central venous catheter Device Related |
ClinicalTrials.gov processed this record on May 19, 2013