[124I]FIAU PET-CT Scanning in Patients With Pain in a Prosthetic Knee or Hip Joint (PJI)

Sensitivity and Specificity of [124I]FIAU PET-CT Scanning in Patients Presenting With Pain in a Prosthetic Knee or Hip Joint

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 Overview

• Status: Terminated
• Conditions: Prosthetic Joint Infections
• Intervention / Treatment: Radiation: [124I]FIAU

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Mobile, Alabama, United States, 36608
      • Coastal Clinical Research, Inc.
  • Arizona
    • Tucson, Arizona, United States, 85712
      • Tucson Orthopaedic Institute
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • University of Arkansas for Medical Sciences
  • Florida
    • Sarasota, Florida, United States, 34232
      • Gulfcoast Research Institute, LLC
    • Tamarac, Florida, United States, 33321
      • Phoenix Clinical Research, LLC
  • Missouri
    • St. Louis, Missouri, United States, 63110
      • Washington University School of Medicine
  • North Carolina
    • Asheville, North Carolina, United States, 28801
      • Mission Hospital
    • Charlotte, North Carolina, United States, 28207
      • OrthoCarolina Research Institute
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Hosptial of the University of Pennsylvania
  • Texas
    • San Antonio, Texas, United States, 78229
      • Clinical Trials of Texas, Incorporated

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Males or females age >18 years
2. Ability to provide informed consent
3. A plain anterior-posterior (AP) and frog leg lateral X-ray of the hip or knee within 6 weeks of enrollment
4. Need for operative intervention in the opinion of the surgeon to correct the pain in the prosthetic joint
5. Prosthetic joint implant that has been in site for more than 3 months prior to enrolment
6. Having adequate general health to be expected to tolerate surgery adn to survive for 6 months from the time of informed consent
7. Women must be either postmenopausal or surgically sterile
8. Ability to return for all study assessments
9. Clinically euthyroid, or on stable thyroid replacement therapy

Exclusion Criteria:

1. Subjects who are unable to comply with study requirements
2. Indication, in the opinion of the principal investigator, for urgent surgery that would preclude the time needed for PET-CT scanning
3. History of an inherited mitochondrial disorder (e.g., Leber's hereditary neuropathy; neuropathy; ataxia, retinitis pigmentosa and ptosis [NARP]; myoneurogenic gastrointestinal encephalopathy [MNGIE]; myocolonic epilepsy with ragged red fibers [MERFF]; and mitochondrial myopathy, encephalomyopathy, lactic acidosis and stroke-like syndrome [MELAS])
4. Alanine aminotransferase (ALT) >5x the upper limit of normal (ULN) OR aspartate aminotransferase (AST) >5X ULN
5. Creatinine clearance <30 mL/min
6. Body mass that exceeds the rating of the CT table
7. Hypersensitivity to iodine
8. Any condition that would put the subject at reasonable risk in the opinion of the investigator

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: [124I]FIAU; Single dose study of [124I]FIAU in patients presenting with pain in a prosthetic knee or hip joint who will undergo PET-CT scanning.	Radiation: [124I]FIAU; 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.; Other Names: Fialuridine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	30 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	30 +/- 2 days
Understand the Prevalence of Prosthetic Joint Infection	The trial failed primary outcome, and this secondary outcome was not analyzed	30 +/- 2 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Explore Whether the Adjudication Committee Evaluation of a Subject's Infection Status Correlates With Either of the Two Proposed Published Standards	An independent adjudication committee will assess the totality of clinical information from each subject and assign them a status of infected or uninfected. The subject's infection status will be compared with either of the two proposed published standards to determine whether it corelates with any of the current consensus definitions or diagnostic algorithms. The trial failed primary outcome, and this secondary outcome was not analyzed.	30 +/- 2 days
Estimate the Sensitivity and Specificity of Plain X-ray in Detecting Prosthetic Joint Infection	The adjudication committee evaluation of a subject's infection status will be used as the standard of truth to which X-ray is compared. The trial failed primary outcome, and this secondary outcome was not analyzed.	15 mins
Determine the Sensitivity and Specificity of [124I]FIAU vs. Plain X-ray in Detecting Prosthetic Joint Infection	The adjudication committee evaluation of a subject's infection status will be used as the standard of truth to which [124I]FIAU and X-ray are compared. The trial failed primary outcome, and this secondary outcome was not analyzed.	30 hours

Collaborators and Investigators

• Sponsor: BioMed Valley Discoveries, Inc

Study record dates

Study Major Dates

• Study Start: August 1, 2012
• Primary Completion (ACTUAL): May 1, 2013
• Study Completion (ACTUAL): November 1, 2013

Study Registration Dates

• First Submitted: October 10, 2012
• First Submitted That Met QC Criteria: October 10, 2012
• First Posted (ESTIMATE): October 12, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): March 7, 2016
• Last Update Submitted That Met QC Criteria: February 8, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Keywords: Infection; Phase II; PET-CT; Joint; Prosthetic; FIAU; Fialuridine
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Fialuridine
• Other Study ID Numbers: BVD002