This protocol will evaluate the sensitivity and specificity of \[124I\]FIAU as a diagnostic imaging agent for the detection of prosthetic joint infections in patients.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
23
This is a single dose study of 5 mCi \[124I\]FIAU in subjects presenting with pain in a prosthetic knee or hip joint. Subject will receive two PET-CT scans after \[124I\]FIAU injection.
Coastal Clinical Research, Inc.
Mobile, Alabama, United States
Tucson Orthopaedic Institute
Tucson, Arizona, United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
Estimate the Sensitivity and Specificity of [124I]FIAU
The sensitivity and specificity of \[124I\]FIAU in the detection of prosthetic joint infection was determined based on the correlation of the patient's infection status determined by an independent image reviewer and the infection status assessed by an adjudication committee. * Presence or absence of infection: Images were to be assessed and optimized on an ongoing basis. The single blinded reader was to assess independently the PET-CT images (attenuation corrected \[AC\] and non-AC PET plus the AC CT) and provide a diagnosis (infected or uninfected) using the chosen parameter(s) without knowing the results of the surgery. The radiology reviewer was not given any additional clinical information on the patient for reassessments relative to the initial reads. A separate central radiologist was to read the comparator X-rays independently for the presence or absence of infection. All pathology slides were to be read by a single pathologist. Local microbiology results were to be used.
Time frame: 30 hours
Evaluate the Safety and Tolerability of [124I]FIAU
Safety will be monitored throughout the study for all subjects. safety will be assessed by monitoring of adverse events,vital signs,physical exams, and clinical laboratory tests including CBC, serum chemistry.
Time frame: 30 +/- 2 days
Define PET-CT Interpretation Criteria That Best Differentiate Infected vs Non-infected Prosthetic Joints
The efficacy of \[124I\]FIAU could not be established due to the non-specific nature of the PET-CT signals caused by the metal artifacts from the prosthesis and pronounced muscle uptake of FIAU. It was impossible to define image review parameters for diagnosis of prosthetic joint infection.
Time frame: 30 +/- 2 days
Understand the Prevalence of Prosthetic Joint Infection
The trial failed primary outcome, and this secondary outcome was not analyzed
Time frame: 30 +/- 2 days
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Gulfcoast Research Institute, LLC
Sarasota, Florida, United States
Phoenix Clinical Research, LLC
Tamarac, Florida, United States
Washington University School of Medicine
St Louis, Missouri, United States
Mission Hospital
Asheville, North Carolina, United States
OrthoCarolina Research Institute
Charlotte, North Carolina, United States
Hosptial of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Clinical Trials of Texas, Incorporated
San Antonio, Texas, United States