NCT07430475

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
266

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 4, 2022

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 29, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 29, 2024

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

February 18, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 24, 2026

Completed
Last Updated

February 24, 2026

Status Verified

February 1, 2026

Enrollment Period

2.1 years

First QC Date

February 18, 2026

Last Update Submit

February 18, 2026

Conditions

Keywords

FDG-PET/CTPETfever of unknown origin

Outcome Measures

Primary Outcomes (1)

  • Diagnostic yield

    • 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

    30 days

Secondary Outcomes (3)

  • Clinical change in management

    30 days

  • Change in antimicrobial management

    30 days

  • Final diagnosis

    30 days

Study Arms (8)

Infectious diseases consultation

Diagnostic Test: 18F-FDG PET/CT

No infectious diseases consultation

Diagnostic Test: 18F-FDG PET/CT

Significant pre-PET imaging finding

Diagnostic Test: 18F-FDG PET/CT

No significant pre-PET imaging finding

Diagnostic Test: 18F-FDG PET/CT

High blood WCC prior to PET

Diagnostic Test: 18F-FDG PET/CT

Low WCC prior to PET

Diagnostic Test: 18F-FDG PET/CT

High CRP prior to PET

Diagnostic Test: 18F-FDG PET/CT

Low CRP prior to PET

Diagnostic Test: 18F-FDG PET/CT

Interventions

18F-FDG PET/CTDIAGNOSTIC_TEST

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

High CRP prior to PETHigh blood WCC prior to PETInfectious diseases consultationLow CRP prior to PETLow WCC prior to PETNo infectious diseases consultationNo significant pre-PET imaging findingSignificant pre-PET imaging finding

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Consecutive adults referred for FDG-PET/CT for evaluation of undifferentiated fever, inflammation or infection.

You may qualify if:

  • 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\*

You may not qualify if:

  • \- 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royal Adelaide Hospital

Adelaide, South Australia, 5000, Australia

Location

MeSH Terms

Conditions

Fever of Unknown OriginFeverInflammation

Condition Hierarchy (Ancestors)

Body Temperature ChangesSigns and SymptomsPathological Conditions, Signs and SymptomsPathologic Processes

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

February 18, 2026

First Posted

February 24, 2026

Study Start

January 4, 2022

Primary Completion

January 29, 2024

Study Completion

January 29, 2024

Last Updated

February 24, 2026

Record last verified: 2026-02

Locations