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

Phase 2

Terminated

• Conditions: Prosthetic Joint Infections
• Interventions: Radiation: [124I]FIAU

• Registration Number: NCT01705496
• Lead Sponsor: BioMed Valley Discoveries, Inc

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-08
• Study First Submitted: 2012-10-10
• Study First Submitted QC: 2012-10-10
• Study First Posted: 2012-10-12
• Primary Completion: 2013-05
• Study Completion: 2013-11
• Results First Submitted: 2016-01-11
• Status Verified: 2016-02
• Results First Submitted QC: 2016-02-08
• Last Update Submitted: 2016-02-08
• Results First Posted: 2016-03-07
• Last Update Posted: 2016-03-07

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 23

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
[124I]FIAU	[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.

Primary Outcome Measures

Name	Time	Method
Estimate the Sensitivity and Specificity of [124I]FIAU	30 hours	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.

Secondary Outcome Measures

Name	Time	Method
Understand the Prevalence of Prosthetic Joint Infection	30 +/- 2 days	The trial failed primary outcome, and this secondary outcome was not analyzed
Evaluate the Safety and Tolerability of [124I]FIAU	30 +/- 2 days	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.
Define PET-CT Interpretation Criteria That Best Differentiate Infected vs Non-infected Prosthetic Joints	30 +/- 2 days	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.

Trial Locations

Locations (10)

Gulfcoast Research Institute, LLC; 🇺🇸 Sarasota, Florida, United States

Tucson Orthopaedic Institute; 🇺🇸 Tucson, Arizona, United States

University of Arkansas for Medical Sciences; 🇺🇸 Little Rock, Arkansas, United States

Mission Hospital; 🇺🇸 Asheville, North Carolina, United States

Washington University School of Medicine; 🇺🇸 St. Louis, Missouri, United States

OrthoCarolina Research Institute; 🇺🇸 Charlotte, North Carolina, United States

Hosptial of the University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States

Phoenix Clinical Research, LLC; 🇺🇸 Tamarac, Florida, United States

Coastal Clinical Research, Inc.; 🇺🇸 Mobile, Alabama, United States

Clinical Trials of Texas, Incorporated; 🇺🇸 San Antonio, Texas, United States