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

Diabetic Foot Infection Clinical Trial

Official title:

Comparaison Entre la Performance du 18F-FDG PET/CT et de la Scintigraphie Osseuse/Gallium ou de la Scintigraphie Osseuse/Globules Blancs marqués /Souffre colloïdal Dans le Diagnostic d'Une ostéomyélite du Pied ou de la Cheville

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03712046
• Other study ID #: 18.200
• Status: Terminated
• Phase: N/A
• Start date: January 15, 2019
• Est. completion date: November 10, 2019

Study information

• Verified date: July 2019
• Source: Centre hospitalier de l'Université de Montréal (CHUM)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: November 10, 2019
• Est. primary completion date: November 10, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Foot
• Diabetic Foot Infection

Intervention

Diagnostic Test:
• 18F-FDG PET-CT
Patient will receive one injection of 18F-FDG and then undergo PET-CT imaging

Locations

Country	Name	City	State
Canada	CHUM	Montréal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Centre hospitalier de l'Université de Montréal (CHUM)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic accuracy of 18F-FDG PET-CT for the diagnosis of diabetic foot osteomyelitis		3 months