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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 : Recruiting
First Posted : October 19, 2018
Last Update Posted : July 24, 2019
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Diabetic Foot Infection Diagnostic Test: 18F-FDG PET-CT Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Diagnostic accuracy of 18F-FDG PET-CT for the diagnosis of diabetic foot osteomyelitis [ Time Frame: 3 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Contacts
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Contact: Daniel Juneau, MD 1-514-890-8180 daniel.juneau@umontreal.ca

Locations
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Canada, Quebec
CHUM Recruiting
Montréal, Quebec, Canada
Contact: Daniel Juneau, MD    514-890-8180    daniel.juneau@umontreal.ca   
Sponsors and Collaborators
Centre hospitalier de l'Université de Montréal (CHUM)

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Responsible Party: Centre hospitalier de l'Université de Montréal (CHUM)
ClinicalTrials.gov Identifier: NCT03712046     History of Changes
Other Study ID Numbers: 18.200
First Posted: October 19, 2018    Key Record Dates
Last Update Posted: July 24, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Diabetic Foot
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Foot Ulcer
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies
Fluorodeoxyglucose F18
Radiopharmaceuticals
Molecular Mechanisms of Pharmacological Action