Novel Gallium 68 Citrate in Orthopedic Infections

Sponsor

Rutgers, The State University of New Jersey (Other)

Overall Status

Terminated

CT.gov ID

NCT03123289

Collaborator

(none)

Enrollment

Location

Arms

43.3

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Joint Prosthesis	Drug: 68-Gallium citrate PET/CT scan Drug: 18F FDG PET/CT scan	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

1 participants

Allocation:

Non-Randomized

Intervention Model:

Crossover Assignment

Intervention Model Description:

Same patients are scanned with two radiotracers within 24-48 hours. Results of the two scans are compared against each other.Same patients are scanned with two radiotracers within 24-48 hours. Results of the two scans are compared against each other.

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

Novel Gallium 68 Citrate in Orthopedic Infections

Actual Study Start Date :

Mar 6, 2017

Actual Primary Completion Date :

Oct 14, 2020

Actual Study Completion Date :

Oct 14, 2020

Arms and Interventions

Arm	Intervention/Treatment
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.	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.
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.	Drug: 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.

Arm

Intervention/Treatment

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.

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.

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.

Drug: 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.

Outcome Measures

Primary Outcome Measures

68Gallium-citrate and 18F-FDG uptake (SUV) surrounding the femoral and acetabular components of the prosthesis [1 year]
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.

Secondary Outcome Measures

Sensitivity, specificity, and accuracy of 68Gallium-citrate and 18F-FDG scans, by using surgical pathology results as the gold standard. [1 year]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Rutgers New Jersey Medical School	Newark	New Jersey	United States	07103

Sponsors and Collaborators

Rutgers, The State University of New Jersey

Investigators

Principal Investigator: Nasrin Ghesani, MD, Rutgers University

Study Documents (Full-Text)

More Information

Publications

None provided.

Responsible Party:

Nasrin Ghesani, Associate Professor, Icahn School of Medicine at Mount Sinai

ClinicalTrials.gov Identifier:

NCT03123289

Other Study ID Numbers:

20160000134

First Posted:

Apr 21, 2017

Last Update Posted:

Apr 15, 2021

Last Verified:

Apr 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Nasrin Ghesani, Associate Professor, Icahn School of Medicine at Mount Sinai

PET/CT

68Gallium Citrate

Orthopedic Hardware infection

Additional relevant MeSH terms:

Infections

Gallium citrate

Study Results

No Results Posted as of Apr 15, 2021