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

Sponsor
Centre hospitalier de l'Université de Montréal (CHUM) (Other)
Overall Status
Terminated
CT.gov ID
NCT03712046
Collaborator
(none)
2
Enrollment
1
Location
1
Arm
9.8
Actual Duration (Months)
0.2
Patients Per Site Per Month

Study Details

Study Description

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
  • Diagnostic Test: 18F-FDG PET-CT
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
2 participants
Allocation:
N/A
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 :
Jan 15, 2019
Actual Primary Completion Date :
Nov 10, 2019
Actual Study Completion Date :
Nov 10, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Diagnostic accuracy of 18F-FDG PET-CT for the diagnosis of diabetic foot osteomyelitis [3 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 CHUM Montréal Quebec Canada

Sponsors and Collaborators

  • Centre hospitalier de l'Université de Montréal (CHUM)

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Centre hospitalier de l'Université de Montréal (CHUM)
ClinicalTrials.gov Identifier:
NCT03712046
Other Study ID Numbers:
  • 18.200
First Posted:
Oct 19, 2018
Last Update Posted:
Nov 13, 2019
Last Verified:
Jul 1, 2019
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Diabetic Foot
Fluorodeoxyglucose F18

Study Results

No Results Posted as of Nov 13, 2019