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

February 18, 2026 updated by: James Kimber, University of Adelaide
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
266

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Royal Adelaide Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Infectious diseases consultation
Diagnostic test: 18F-FDG PET/CT
Nuclear medicine imaging as a diagnostic tool with implication for change in clinical management
No infectious diseases consultation
Diagnostic test: 18F-FDG PET/CT
Nuclear medicine imaging as a diagnostic tool with implication for change in clinical management
Significant pre-PET imaging finding
Diagnostic test: 18F-FDG PET/CT
Nuclear medicine imaging as a diagnostic tool with implication for change in clinical management
No significant pre-PET imaging finding
Diagnostic test: 18F-FDG PET/CT
Nuclear medicine imaging as a diagnostic tool with implication for change in clinical management
High blood WCC prior to PET
Diagnostic test: 18F-FDG PET/CT
Nuclear medicine imaging as a diagnostic tool with implication for change in clinical management
Low WCC prior to PET
Diagnostic test: 18F-FDG PET/CT
Nuclear medicine imaging as a diagnostic tool with implication for change in clinical management
High CRP prior to PET
Diagnostic test: 18F-FDG PET/CT
Nuclear medicine imaging as a diagnostic tool with implication for change in clinical management
Low CRP prior to PET
Diagnostic test: 18F-FDG PET/CT
Nuclear medicine imaging as a diagnostic tool with implication for change in clinical management

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
30 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
30 days
Change in antimicrobial management
Time Frame: 30 days
•Change in antimicrobial duration/spectrum/therapeutic procedure: this change occurred as a result of PET
30 days
Final diagnosis
Time Frame: 30 days
• Final diagnosis: infection = 1, non-infectious = 2, malignancy = 3, unresolved = 4
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Adelaide

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Central Adelaide Local Health Network Incorporated

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 4, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 29, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 29, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 18, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 18, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 24, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 24, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 18, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 20340

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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