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Novel Gallium 68 Citrate in Orthopedic Infections

Primary Purpose

Joint Prosthesis

Status

Terminated

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

68-Gallium citrate PET/CT scan

18F FDG PET/CT scan

About this trial

This is an interventional diagnostic trial for Joint Prosthesis focused on measuring PET/CT, 68Gallium Citrate, Orthopedic Hardware infection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

Rutgers New Jersey Medical School

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

68Gallium-citrate

18F-FDG

Arm 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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT03123289

First Posted

April 4, 2017

Last Updated

April 12, 2021

Sponsor

Rutgers, The State University of New Jersey

1. Study Identification

Unique Protocol Identification Number

NCT03123289

Brief Title

Novel Gallium 68 Citrate in Orthopedic Infections

Official Title

Novel Gallium 68 Citrate in Orthopedic Infections

Study Type

Interventional

2. Study Status

Record Verification Date

April 2021

Overall Recruitment Status

Terminated

Why Stopped

PI left the institute and the funding expired.

Study Start Date

March 6, 2017 (Actual)

Primary Completion Date

October 14, 2020 (Actual)

Study Completion Date

October 14, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Rutgers, The State University of New Jersey

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Joint Prosthesis

Keywords

PET/CT, 68Gallium Citrate, Orthopedic Hardware infection

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 2

Interventional Study Model

Crossover Assignment

Model Description

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)

Allocation

Non-Randomized

Enrollment

1 (Actual)

8. Arms, Groups, and Interventions

Arm Title

68Gallium-citrate

Arm Type

Experimental

Arm Description

Arm Title

18F-FDG

Arm Type

Experimental

Arm 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.

Intervention Type

Drug

Intervention Name(s)

68-Gallium citrate PET/CT scan

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

18F FDG PET/CT scan

Intervention Description

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.

Primary Outcome Measure Information:

Title

68Gallium-citrate and 18F-FDG uptake (SUV) surrounding the femoral and acetabular components of the prosthesis

Description

Time Frame

1 year

Secondary Outcome Measure Information:

Title

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

Description

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Nasrin Ghesani, MD

Organizational Affiliation

Rutgers University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Rutgers New Jersey Medical School

City

Newark

State/Province

New Jersey

ZIP/Postal Code

07103

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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Novel Gallium 68 Citrate in Orthopedic Infections

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