Novel Gallium 68 Citrate in Orthopedic Infections

• Status: Terminated
• Trial end date: 2020-10-14
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rutgers, The State University of New Jersey
• Treatments: Citric Acid; Fluorodeoxyglucose F18; Gallium citrate

Criteria

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)