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Completed

NCT Number: NCT07430475

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Royal Adelaide Hospital

Adelaide, South Australia, 5000, Australia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

18F-FDG PET/CT

Diagnostic Test

Nuclear medicine imaging as a diagnostic tool with implication for change in clinical management

Primary outcomes

  1. 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

  1. Clinical change in management

    Time frame: 30 days

    • Clinical change in management: was clinical care altered compared to the documented plan prior to PET? 0 = no, 1 = yes
    • Yes: antimicrobial therapy, procedures/interventions (PET-guided site biopsy, or surgery/drainage), diagnostics e.g. further focussed imaging, or disposition e.g. palliative care transition
    • No: there was no change to the management plan, or the plan was already determined by other data

    Examples:

    • PET confirmed a suspected diagnosis but the treatment plan was unchanged
    • PET provided supporting evidence but no explicit management adjustment was documented
    • PET was negative and no further management steps were taken because there was a pre-existing plan
  2. Change in antimicrobial management

    Time frame: 30 days

    •Change in antimicrobial duration/spectrum/therapeutic procedure: this change occurred as a result of PET

  3. Final diagnosis

    Time frame: 30 days

    • Final diagnosis: infection = 1, non-infectious = 2, malignancy = 3, unresolved = 4

Sponsors and collaborators

Lead sponsor

University of Adelaide

Other

Collaborators

  • Central Adelaide Local Health Network Incorporated

Registry information

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Feb 24, 2026
Registry last updated
Feb 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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