Comparison of FDG PET and Bone Scintigraphy/Labelled Leukocyte/Gallium Scintigraphy in Diabetic Foot Osteomyelitis
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|ClinicalTrials.gov Identifier: NCT03712046|
Recruitment Status : Terminated (Poor patient recruitment)
First Posted : October 19, 2018
Last Update Posted : November 13, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Diabetic Foot Infection||Diagnostic Test: 18F-FDG PET-CT||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||January 15, 2019|
|Actual Primary Completion Date :||November 10, 2019|
|Actual Study Completion Date :||November 10, 2019|
Experimental: Main arm
PET-CT imaging of the ankles and feet following injection of 18F-FDG
Diagnostic Test: 18F-FDG PET-CT
Patient will receive one injection of 18F-FDG and then undergo PET-CT imaging
- Diagnostic accuracy of 18F-FDG PET-CT for the diagnosis of diabetic foot osteomyelitis [ Time Frame: 3 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03712046
|Montréal, Quebec, Canada|