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Clinical Trials/NCT07430475
NCT07430475CompletedNot Applicable

Utility of 18F-FDG PET/CT for Suspected Infection in the Inpatient Setting: a Single Centre Retrospective Cohort Study

University of Adelaide1 site in 1 country266 target enrollmentStarted: January 4, 2022Last updated:
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
266
Locations
1
Primary Endpoint
Diagnostic yield

Study Overview

Brief Summary

Retrospective cohort study of inpatients at a South Australian tertiary hospital who underwent 18F FDG-PET/CT for investigation of undifferentiated fever or inflammatory syndrome. The aim is to investigate the utility of FDG-PET/CT in the investigation of suspected infection in hospitalised adults. To establish the rate at which FDG-PET/CT contributes to a diagnosis, and how this impacts clinical management and outcomes. From this, to develop further understanding of for which patients this imaging modality contributes meaningfully to outcomes.

Detailed Description

A retrospective cohort study of consecutive adult inpatients undergoing 18F-FDG PET/CT for suspected infection or inflammation, excluding infective endocarditis and malignancy-directed scans. Pre-PET variables include inflammatory markers, microbiological results, prior imaging findings and infectious diseases (ID) consultation. PET/CT utility will be adjudicated as diagnostic and/or associated with a change in management using a structured consensus process. Associations between pre-PET factors and clinical utility will be explored using descriptive and logistic analyses.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Retrospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Inpatient at the Royal Adelaide Hospital
  • FDG-PET/CT between 1st January 2022 - 31st December 2023
  • Imaging request query included: infect* AND/OR Fever of Unknown Origin OR FUO AND/OR Pyrexia of Unknown Origin OR PUO AND/OR inflammat*

Exclusion Criteria

  • - Outpatient PET/CT
  • Comparison imaging for established diagnosed infection
  • PET/CT intended for evaluation of malignancy
  • Evaluation of presumed or confirmed infective endocarditis
  • Age less than 18 years

Arms & Interventions

Low CRP prior to PET

Intervention: 18F-FDG PET/CT (Diagnostic Test)

Infectious diseases consultation

Intervention: 18F-FDG PET/CT (Diagnostic Test)

No infectious diseases consultation

Intervention: 18F-FDG PET/CT (Diagnostic Test)

Significant pre-PET imaging finding

Intervention: 18F-FDG PET/CT (Diagnostic Test)

No significant pre-PET imaging finding

Intervention: 18F-FDG PET/CT (Diagnostic Test)

High blood WCC prior to PET

Intervention: 18F-FDG PET/CT (Diagnostic Test)

Low WCC prior to PET

Intervention: 18F-FDG PET/CT (Diagnostic Test)

High CRP prior to PET

Intervention: 18F-FDG PET/CT (Diagnostic Test)

Outcomes

Primary Outcomes

Diagnostic yield

Time Frame: 30 days

• Did PET contribute to diagnostic yield?: * 1 = Yes: PET led to a finding either definitive e.g. confirmed by gold standard (microbiology, histopathology, intraoperative findings etc) or contributory, which guided diagnosis or management even without gold standard confirmation. Examples of contributory: PET showing vascular graft uptake, not explanted due to risk but presumptively treated Vertebral discitis suggested by PET, biopsied without culture, but presumptively treated and clinically improved PET negative - antibiotics ceased, patient remained well * 0 = No: PET provided no new information, was misleading (i.e. PET result contradicted by later results), or no action was taken based on PET

Secondary Outcomes

  • Clinical change in management(30 days)
  • Change in antimicrobial management(30 days)
  • Final diagnosis(30 days)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

James Kimber

Dr

University of Adelaide

Study Sites (1)

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