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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07430475
Enrollment
266
Registered
2026-02-24
Start date
2022-01-04
Completion date
2024-01-29
Last updated
2026-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fever, Fever of Unknown Origin, Inflammation, Inflammation of Unknown Origin

Keywords

FDG-PET/CT, PET, fever of unknown origin

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.

Interventions

DIAGNOSTIC_TEST18F-FDG PET/CT

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

Sponsors

University of Adelaide
Lead SponsorOTHER
Central Adelaide Local Health Network Incorporated
CollaboratorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Diagnostic yield30 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

MeasureTime frameDescription
Clinical change in management30 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
Change in antimicrobial management30 days•Change in antimicrobial duration/spectrum/therapeutic procedure: this change occurred as a result of PET
Final diagnosis30 days• Final diagnosis: infection = 1, non-infectious = 2, malignancy = 3, unresolved = 4

Countries

Australia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 25, 2026