Novel Gallium 68 Citrate in Orthopedic Infections

Status: Terminated
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
New Jersey
Rutgers New Jersey Medical School
Newark
Time Frame
Start Date: 2017-03-06
Completion Date: 2020-10-14
Participants
Target number of participants: 1
Treatments
Experimental: 68Gallium-citrate
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.
Experimental: 18F-FDG
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.
Sponsors
Leads: Rutgers, The State University of New Jersey

This content was sourced from clinicaltrials.gov

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