Comparison of FDG PET and Bone Scintigraphy/Labelled Leukocyte/Gallium Scintigraphy in Diabetic Foot Osteomyelitis

Not Applicable

Terminated

• Conditions: Diabetic Foot Infection
• Interventions: Diagnostic Test: 18F-FDG PET-CT

• Registration Number: NCT03712046
• Lead Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)

Brief Summary

Diabetic foot osteomyelitis is a common and serious complication of diabetes. While the diagnosis of soft tissue infection can be made with simple physical examination in most cases, bone involvement can be harder to diagnose, often requiring medical imaging. In addition to conventional radiological examinations (x-ray and MRI) nuclear medicine procedures can also provide important physiological information in these patients. These procedures include triple phase bone scan combined with Gallium scintigraphy or a combination of labelled leukocyte scintigraphy and bone marrow scintigraphy using sulfur colloid. These procedure, while they provide useful physiological information, are time consuming, generally requiring at least 2 separate image acquisition on separate days, and can be costly.

18F-FDG is a glucose analog that can be used for PET imaging. In addition to its application in oncology, the literature has shown that FDG can be used to investigate a wide variety of inflammatory and infectious conditions, including diabetic foot infections.

The aim of this study is to compare the usefulness of FDG PET imaging versus "conventional" nuclear medicine (either bone scan and Gallium scintigraphy or labelled leukocytes and sulfur colloid scintigraphy) in patient with suspected diabetic foot osteomyelitis.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-10-17
• Study First Submitted QC: 2018-10-17
• Study First Posted: 2018-10-19
• Study Start: 2019-01-15
• Status Verified: 2019-07
• Primary Completion: 2019-11-10
• Study Completion: 2019-11-10
• Last Update Submitted: 2019-11-10
• Last Update Posted: 2019-11-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

Inclusion Criteria

• Diabetic patient with suspected diabetic foot osteomyelitis referred for nuclear medicine examination (bone scan and Gallium or labelled leukocytes).
• Being treated or followed by a physician at CHUM

Exclusion Criteria

• Pregnant woman
• Breastfeeding patient
• Claustrophobia/patient unable to complete imaging procedure

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Main arm	18F-FDG PET-CT	PET-CT imaging of the ankles and feet following injection of 18F-FDG

Primary Outcome Measures

Name	Time	Method
Diagnostic accuracy of 18F-FDG PET-CT for the diagnosis of diabetic foot osteomyelitis	3 months

Trial Locations

Locations (1)

CHUM; 🇨🇦 Montréal, Quebec, Canada