Novel Gallium 68 Citrate in Orthopedic Infections

Rutgers The State University of New Jersey

Status and phase: Terminated; Phase 2

Conditions: Joint Prosthesis

Treatments: Drug: 68-Gallium citrate PET/CT scan; Drug: 18F FDG PET/CT scan

Study type: Interventional

Funder types: Other

Identifiers

NCT03123289

20160000134

Details and patient eligibility

About

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.

Enrollment: 1 patient

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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1 participants in 2 patient groups

68Gallium-citrate

Experimental group

Description:

This arm, undergoing the "68-Gallium citrate PET/CT scan intervention", includes the PET/CT scans performed with 68Gallium-citrate radiotracer. Note that same patients scanned with different radiotracers serve in both arms.

Treatment:

Drug: 68-Gallium citrate PET/CT scan

18F-FDG

Experimental group

Description:

This arm, undergoing the "18F FDG PET/CT scan intervention", includes the PET/CT scans performed with 18F-FDG tracer. Note that same patients scanned with different radiotracers serve in both arms.

Treatment:

Drug: 18F FDG PET/CT scan