Novel Gallium 68 Citrate in Orthopedic Infections



Status:Suspended
Conditions:Infectious Disease
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - Any
Updated:8/19/2018
Start Date:March 6, 2017
End Date:December 30, 2020

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Trial Summary
Trial Overview
Inclusion Criteria
In the proposed study, our aim is to evaluate the uptake of 68Gallium-citrate in patients
with failed joint prosthesis and compare it with that of conventional
18fluorine-fluorodeoxyglucose (18F-FDG) positron emission tomography/computed tomography
(PET/CT) scan. We will perform PET/CT scan with 68Gallium citrate and 18F-FDG in subjects
with failed hip or knee prosthesis. Both 68Gallium-citrate and 18F-FDG scans, done within
24-48 hours from each other, will be performed within 4 weeks before surgical
evaluation/revision of the hardware.


Inclusion Criteria:

- At least 6 months after hip replacement with complaint of joint pain.

- Radiographic studies compatible with prosthesis loosening (i.e. periprosthetic
infection or aseptic loosening).

- Pending surgical evaluation and tissue sampling within the next few weeks to
differentiate between infection and aseptic loosening.

Exclusion Criteria:

- Inability to consent

- Pregnancy or known or suspected hypersensitivity to metals or gallium

- Joint replacement for any reason other than primary or secondary osteoarthritis

- Prior surgical therapy for prosthesis failure after initial hospital discharge

- Active inflammatory/infectious process at any location other than prosthetic joint
(Sarcoidosis, Rheumatoid arthritis, HIV infection, SLE)
We found this trial at
1
site
Rutgers New Jersey Medical School
Newark, New Jersey 07103
Principal Investigator: Nasrin Ghesani, MD
Phone: 973-972-1770
?
mi
from
Newark, NJ
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