Novel Gallium 68 Citrate in Orthopedic Infections

Joint Prosthesis Clinical Trial

Official title:

Novel Gallium 68 Citrate in Orthopedic Infections

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03123289
• Other study ID #: 20160000134
• Status: Terminated
• Phase: Phase 2
• Start date: March 6, 2017
• Est. completion date: October 14, 2020

Study information

• Verified date: April 2021
• Source: Rutgers, The State University of New Jersey
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: October 14, 2020
• Est. primary completion date: October 14, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Infection
• Joint Prosthesis

Intervention

Drug:
• 68-Gallium citrate PET/CT scan
After establishment of an intravenous access, approximately 5 mCi of 68Ga-citrate (Zevacor Molecular, Somerset, NJ, USA) will be administered intravenously. Whole body PET/CT scan will be performed after 60 minutes of uptake phase.
• 18F FDG PET/CT scan
Subjects will undergo FDG PET/CT scan using the same imaging parameters either on the same day or within the next 24-48 hours. The subjects will be requested to fast for a minimum of 4 h prior to PET acquisition. After confirmation of a blood glucose level =200 mg/dl, technologists will establish the intravenous access and the subject will receive approximately 10 mCi of 18F-FDG (Zevacor Molecular, Somerset, NJ, USA) intravenously. The subject will be placed in uptake room for 60 minutes to allow for optimal localization of the compound. The subjects will be requested to void prior to administration of 18FDG and again prior to image acquisition.

Locations

Country	Name	City	State
United States	Rutgers New Jersey Medical School	Newark	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Rutgers, The State University of New Jersey

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	68Gallium-citrate and 18F-FDG uptake (SUV) surrounding the femoral and acetabular components of the prosthesis	The radiotracer uptake in SUV units is measured in different Gruen zones around the prosthesis and normalized by that of the liver. The values of the two scans will be compared against each other for all patients.	1 year
Secondary	Sensitivity, specificity, and accuracy of 68Gallium-citrate and 18F-FDG scans, by using surgical pathology results as the gold standard.	Using the surgical histology and tissue culture as the gold standard, sensitivity and specificity of both techniques will be calculated. The aim is determine which modality has more accuracy to differentiate septic prosthesis failure from aseptic entities.	1 year