[124I]FIAU PET-CT Scanning in Patients With Pain in a Prosthetic Knee or Hip Joint
Status: | Terminated |
---|---|
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 4/21/2016 |
Start Date: | August 2012 |
End Date: | November 2013 |
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.
imaging agent for the detection of prosthetic joint infections in patients.
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
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529 West Markham Street
Little Rock, Arkansas 72205
Little Rock, Arkansas 72205
(501) 686-7000
University of Arkansas for Medical Sciences The University of Arkansas for Medical Sciences (UAMS) in...
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