Novel Gallium 68 Citrate in Orthopedic Infections

NCT03123289 | Terminated Phase 2 FDA Drug

• 1 other identifier: 20160000134
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Joint Prosthesis

Keywords

PET/CT; 68Gallium Citrate; Orthopedic Hardware infection

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

  1 year

Study Arms (2)

68Gallium-citrate

EXPERIMENTAL

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

18F-FDG

EXPERIMENTAL

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

Interventions

68-Gallium citrate PET/CT scan DRUG

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.

68Gallium-citrate

18F FDG PET/CT scan DRUG

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.

18F-FDG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead

Study Sites (1)

Rutgers New Jersey Medical School

Newark, New Jersey, 07103, United States

Location

Study Officials

• Nasrin Ghesani, MD

  Rutgers University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

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

Study Record Dates

• First Submitted: April 4, 2017
• First Posted: April 21, 2017
• Study Start: March 6, 2017
• Primary Completion: October 14, 2020
• Study Completion: October 14, 2020
• Last Updated: April 15, 2021

Record last verified: 2021-04

Locations

US (1)