Infection Clinical Trial
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
| NCT number | NCT01434797 |
| Other study ID # | 89/11 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | September 2011 |
| Est. completion date | March 2020 |
| Verified date | March 2020 |
| Source | University of Lausanne Hospitals |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 11 |
| Est. completion date | March 2020 |
| Est. primary completion date | November 2014 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Switzerland | Centre Hospitalier Universitaire Vaudois, Nuclear Medicine | Lausanne | Vaud |
| Lead Sponsor | Collaborator |
|---|---|
| University of Lausanne Hospitals |
Switzerland,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | Diagnostic value (sensitivity and sensibility, positive/negative predictive value) of microcalorimetry in the detection of CVCP infection | 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]) | 6 months |
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