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

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: Sensitivity and Specificity of [124I]FIAU PET-CT Scanning in Patients Presenting With Pain in a Prosthetic Knee or Hip Joint

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 Summary:
Sponsor: BioMed Valley Discoveries, Inc

Current Primary Outcome: Estimate the Sensitivity and Specificity of [124I]FIAU [ Time Frame: 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.


Original Primary Outcome: Estimate the Sensitivity and Specificity of [124I]FIAU [ Time Frame: 30 hours ]

Subjects will be dosed with [124I]FIAU. PET-CT scannig will be performed at two time points after dosing.


Current Secondary Outcome:

  • Evaluate the Safety and Tolerability of [124I]FIAU [ Time Frame: 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 [ Time Frame: 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.
  • Understand the Prevalence of Prosthetic Joint Infection [ Time Frame: 30 +/- 2 days ]
    The trial failed primary outcome, and this secondary outcome was not analyzed


Original Secondary Outcome:

  • Evaluate the Safety and Tolerability of [124I]FIAU [ Time Frame: 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 [ Time Frame: 30 +/- 2 days ]
  • Understand the Prevalence of Prosthetic Joint Infection [ Time Frame: 30 +/- 2 days ]


Information By: BioMed Valley Discoveries, Inc

Dates:
Date Received: October 10, 2012
Date Started: August 2012
Date Completion:
Last Updated: February 8, 2016
Last Verified: February 2016