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

Stopped early · Phase 2

Conditions studied: Prosthetic Joint Infections

In brief

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.

Key facts

Study ID

NCT01705496

Run by

BioMed Valley Discoveries, Inc

People needed

23

Starts

2012-08-01

Expected to finish

2013-11-01

Last updated by the study team

2016-03-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• Subjects who are unable to comply with study requirements
• Indication, in the opinion of the principal investigator, for urgent surgery that would preclude the time needed for PET-CT scanning
• 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])
• Alanine aminotransferase (ALT) >5x the upper limit of normal (ULN) OR aspartate aminotransferase (AST) >5X ULN
• Creatinine clearance <30 mL/min
• Body mass that exceeds the rating of the CT table
• Hypersensitivity to iodine
• Any condition that would put the subject at reasonable risk in the opinion of the investigator

Where it is running

• 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
• 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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.