Novel Gallium 68 Citrate in Orthopedic Infections

Stopped early · Phase 2

Conditions studied: Joint Prosthesis

In brief

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.

Key facts

Study ID

NCT03123289

Run by

Rutgers, The State University of New Jersey

People needed

1

Starts

2017-03-06

Expected to finish

2020-10-14

Last updated by the study team

2021-04-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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)

Where it is running

• Rutgers New Jersey Medical School — Newark, New Jersey, United States

Full record on ClinicalTrials.gov

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