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

Primary Purpose

Diabetic Foot Infection

Status
Terminated
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
18F-FDG PET-CT
Sponsored by
Centre hospitalier de l'Université de Montréal (CHUM)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Diabetic Foot Infection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHUM

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Main arm

Arm Description

PET-CT imaging of the ankles and feet following injection of 18F-FDG

Outcomes

Primary Outcome Measures

Diagnostic accuracy of 18F-FDG PET-CT for the diagnosis of diabetic foot osteomyelitis

Secondary Outcome Measures

Full Information

First Posted
October 17, 2018
Last Updated
November 10, 2019
Sponsor
Centre hospitalier de l'Université de Montréal (CHUM)
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1. Study Identification

Unique Protocol Identification Number
NCT03712046
Brief Title
Comparison of FDG PET and Bone Scintigraphy/Labelled Leukocyte/Gallium Scintigraphy in Diabetic Foot Osteomyelitis
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Terminated
Why Stopped
Poor patient recruitment
Study Start Date
January 15, 2019 (Actual)
Primary Completion Date
November 10, 2019 (Actual)
Study Completion Date
November 10, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre hospitalier de l'Université de Montréal (CHUM)

4. Oversight

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

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Foot Infection

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Main arm
Arm Type
Experimental
Arm Description
PET-CT imaging of the ankles and feet following injection of 18F-FDG
Intervention Type
Diagnostic Test
Intervention Name(s)
18F-FDG PET-CT
Intervention Description
Patient will receive one injection of 18F-FDG and then undergo PET-CT imaging
Primary Outcome Measure Information:
Title
Diagnostic accuracy of 18F-FDG PET-CT for the diagnosis of diabetic foot osteomyelitis
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
CHUM
City
Montréal
State/Province
Quebec
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

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

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