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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
BioMed Valley Discoveries, Inc
ClinicalTrials.gov Identifier:
NCT01705496
First received: October 10, 2012
Last updated: August 20, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention Phase
Prosthetic Joint Infections
Radiation: [124I]FIAU
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Sensitivity and Specificity of [124I]FIAU PET-CT Scanning in Patients Presenting With Pain in a Prosthetic Knee or Hip Joint

Resource links provided by NLM:


Further study details as provided by BioMed Valley Discoveries, Inc:

Primary Outcome Measures:
  • Estimate the sensitivity and specificity of [124I]FIAU [ Time Frame: 30 hours ] [ Designated as safety issue: No ]
    Subjects will be dosed with [124I]FIAU. PET-CT scannig will be performed at two time points after dosing.


Secondary Outcome Measures:
  • Evaluate the safety and tolerability of [124I]FIAU [ Time Frame: 30 +/- 2 days ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 30 +/- 2 days ] [ Designated as safety issue: No ]
  • Understand the prevalence of prosthetic joint infection [ Time Frame: 30 +/- 2 days ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Explore whether the adjudication committee evaluation of a subject's infection status correlates with either of the two proposed published standards [ Time Frame: 30 +/- 2 days ] [ Designated as safety issue: No ]
    An independent adjudication committee will assess the totality of clinical information from each subject and assign them a status of infected or uninfected. The subject's infection status will be compared with either of the two proposed published standards to determine whether it corelates with any of the current consensus definitions or diagnostic algorithms.

  • Estimate the sensitivity and specificity of plain X-ray in detecting prosthetic joint infection [ Time Frame: 15 mins ] [ Designated as safety issue: No ]
    The adjudication committee evaluation of a subject's infection status will be used as the standard of truth to which X-ray is compared.

  • Determine the sensitivity and specificity of [124I]FIAU vs. plain X-ray in detecting prosthetic joint infection [ Time Frame: 30 hours ] [ Designated as safety issue: No ]
    The adjudication committee evaluation of a subject's infection status will be used as the standard of truth to which [124I]FIAU and X-ray are compared.


Enrollment: 24
Study Start Date: August 2012
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: [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.
Radiation: [124I]FIAU
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.
Other Name: Fialuridine

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01705496

Locations
United States, Alabama
Coastal Clinical Research, Inc.
Mobile, Alabama, United States, 36608
United States, Arizona
Tucson Orthopaedic Institute
Tucson, Arizona, United States, 85712
United States, Arkansas
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
United States, Florida
Gulfcoast Research Institute, LLC
Sarasota, Florida, United States, 34232
Phoenix Clinical Research, LLC
Tamarac, Florida, United States, 33321
United States, Missouri
Washington University School of Medicine
St. Louis, Missouri, United States, 63110
United States, North Carolina
Mission Hospital
Asheville, North Carolina, United States, 28801
OrthoCarolina Research Institute
Charlotte, North Carolina, United States, 28207
United States, Pennsylvania
Hosptial of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
United States, Texas
Clinical Trials of Texas, Incorporated
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
BioMed Valley Discoveries, Inc
  More Information

No publications provided

Responsible Party: BioMed Valley Discoveries, Inc
ClinicalTrials.gov Identifier: NCT01705496     History of Changes
Other Study ID Numbers: BVD002
Study First Received: October 10, 2012
Last Updated: August 20, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by BioMed Valley Discoveries, Inc:
Phase II
FIAU
Fialuridine
Prosthetic
Joint
Infection
PET-CT

Additional relevant MeSH terms:
Arthritis, Infectious
Infection
Arthritis
Joint Diseases
Musculoskeletal Diseases
Fialuridine
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 31, 2014