18F-FDG PET/CT for Diagnosis of Diabetic Foot Osteomyelitis

ConditionDiabetic Foot Infections

Trial statusNot yet recruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18+

SponsorJewish General Hospital

About this trial

Diabetic foot osteomyelitis (DFO) is a bone infection of the foot that can occur in people with diabetes and may lead to serious complications, including amputation. Diagnosing DFO can be difficult. This prospective multicenter observational study will evaluate how accurately 18F-FDG PET/CT can diagnose DFO in patients who are already referred for this imaging test as part of their clinical care. The study will use current-generation digital PET/CT systems and standardized interpretation criteria. PET/CT findings will be compared with bone biopsy results when available, or with clinical and imaging findings obtained during at least 6 months of follow-up.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial population

Adults with diabetes and suspected diabetic foot infection with concern for osteomyelitis who have been referred by their treating physician for 18F-FDG PET/CT at participating academic centers in Canada and the United States. Approximately 150 consecutive eligible participants will be prospectively enrolled. Clinical care, including the decision to perform bone biopsy or other investigations and treatments, will remain at the discretion of the treating physicians.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

18F-FDG PET/CT
Diagnostic test
18F-FDG PET/CT of the feet performed using current-generation digital PET/CT systems and a standardized acquisition protocol. PET/CT images will subsequently be evaluated using standardized interpretation criteria to determine diagnostic performance for diabetic foot osteomyelitis.

Treatment groups

150 Participants

are divided into 1 treatment group

Group A: Patients with suspected diabetic foot osteomyelitis1 intervention

Trial outcomes

Primary outcomes

Diagnostic accuracy of 18F-FDG PET/CT for diabetic foot osteomyelitis

Diagnostic performance of 18F-FDG PET/CT for diabetic foot osteomyelitis will be assessed by calculating sensitivity, specificity, positive predictive value, and negative predictive value. PET/CT findings will be compared with a reference standard consisting of histopathology from bone biopsy when available, unequivocal cortical erosion/destruction on CT, or clinical and radiographic/CT confirmation during follow-up.

Time frame

At least 6 months after PET/CT

Sponsors and contacts

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Jewish General Hospital

Lead sponsor

Society of Nuclear Medicine and Molecular Imaging (SNMMI) Mars Shot Research Fund

Collaborator

Source ClinicalTrials.gov

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