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

NCT01705496 | Terminated Phase 2 Results

• 1 other identifier: BVD002
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 10

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.

Conditions

Prosthetic Joint Infections

Keywords

Phase II; FIAU; Fialuridine; Prosthetic; Joint; Infection; PET-CT

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Evaluate the Safety and Tolerability of [124I]FIAU

  30 +/- 2 days

• Define PET-CT Interpretation Criteria That Best Differentiate Infected vs Non-infected Prosthetic Joints

  30 +/- 2 days

• Understand the Prevalence of Prosthetic Joint Infection

  30 +/- 2 days

Other Outcomes (3)

• Explore Whether the Adjudication Committee Evaluation of a Subject's Infection Status Correlates With Either of the Two Proposed Published Standards

  30 +/- 2 days

• Estimate the Sensitivity and Specificity of Plain X-ray in Detecting Prosthetic Joint Infection

  15 mins

• Determine the Sensitivity and Specificity of [124I]FIAU vs. Plain X-ray in Detecting Prosthetic Joint Infection

  30 hours

Study Arms (1)

[124I]FIAU

EXPERIMENTAL

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

Interventions

[124I]FIAU RADIATION

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.

Also known as: Fialuridine

[124I]FIAU

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• BioMed Valley Discoveries, Inc: lead

Study Sites (10)

Coastal Clinical Research, Inc.

Mobile, Alabama, 36608, United States

Location

Tucson Orthopaedic Institute

Tucson, Arizona, 85712, United States

Location

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

Gulfcoast Research Institute, LLC

Sarasota, Florida, 34232, United States

Location

Phoenix Clinical Research, LLC

Tamarac, Florida, 33321, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Mission Hospital

Asheville, North Carolina, 28801, United States

Location

OrthoCarolina Research Institute

Charlotte, North Carolina, 28207, United States

Location

Hosptial of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Clinical Trials of Texas, Incorporated

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Infections

Interventions

fialuridine

Results Point of Contact

• Title: Dr. Michelle Zhang, Executive Director
• Organization: Biomed valley discoveries

mzhang@biomed-valley.com

7815339412

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2012
• First Posted: October 12, 2012
• Study Start: August 1, 2012
• Primary Completion: May 1, 2013
• Study Completion: November 1, 2013
• Last Updated: March 7, 2016
• Results First Posted: March 7, 2016

Record last verified: 2016-02

Locations

US (10)