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Value of PET/CT Imaging in the Diagnosis of Permanent Central Venous Catheters Infection
This study is currently recruiting participants.
Verified November 2016 by John O. Prior, 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: November 13, 2016
Last verified: November 2016
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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 John O. Prior, 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 ]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 ]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: | January 2018 |
| Estimated Primary Completion Date: | December 2017 (Final data collection date for primary outcome measure) |
| 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 (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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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01434797
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
| 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: | November 13, 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 |
ClinicalTrials.gov processed this record on July 21, 2017