Clinical trial NCT01705496: [124I]FIAU PET-CT Scanning in Patients With Pain in a Prosthetic Knee or Hip Joint
Official title: Sensitivity and Specificity of [124I]FIAU PET-CT Scanning in Patients Presenting With Pain in a Prosthetic Knee or Hip Joint
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Prosthetic Joint Infections
Keywords: Phase II
FIAU
Fialuridine
Prosthetic
Joint
Infection
PET-CT
Lead sponsor: BioMed Valley Discoveries, Inc
Sponsor class: INDUSTRY
First posted: 2012-10-12
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Estimate the Sensitivity and Specificity of [124I]FIAU
timeFrame: 30 hours
Secondary outcomes:
measure: Evaluate the Safety and Tolerability of [124I]FIAU
timeFrame: 30 +/- 2 days
measure: Define PET-CT Interpretation Criteria That Best Differentiate Infected vs Non-infected Prosthetic Joints
timeFrame: 30 +/- 2 days
measure: Understand the Prevalence of Prosthetic Joint Infection
timeFrame: 30 +/- 2 days
Other outcomes:
measure: Explore Whether the Adjudication Committee Evaluation of a Subject's Infection Status Correlates With Either of the Two Proposed Published Standards
timeFrame: 30 +/- 2 days
measure: Estimate the Sensitivity and Specificity of Plain X-ray in Detecting Prosthetic Joint Infection
timeFrame: 15 mins
measure: Determine the Sensitivity and Specificity of [124I]FIAU vs. Plain X-ray in Detecting Prosthetic Joint Infection
timeFrame: 30 hours
Locations:
city: Mobile
country: United States
facility: Coastal Clinical Research, Inc.
state: Alabama
city: Tucson
country: United States
facility: Tucson Orthopaedic Institute
state: Arizona
city: Little Rock
country: United States
facility: University of Arkansas for Medical Sciences
state: Arkansas
city: Sarasota
country: United States
facility: Gulfcoast Research Institute, LLC
state: Florida
city: Tamarac
country: United States
facility: Phoenix Clinical Research, LLC
state: Florida
city: St. Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Asheville
country: United States
facility: Mission Hospital
state: North Carolina
city: Charlotte
country: United States
facility: OrthoCarolina Research Institute
state: North Carolina
city: Philadelphia
country: United States
facility: Hosptial of the University of Pennsylvania
state: Pennsylvania
city: San Antonio
country: United States
facility: Clinical Trials of Texas, Incorporated
state: Texas
Study officials:
References: