Clinical Trial: [124I]FIAU PET-CT Scanning in Diagnosing Osteomyelitis in Patients With Diabetic Foot Infection

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

Official Title: Exploration of the Use of [124I]FIAU Positron Emission Tomography-Computed Tomography Scanning in Diagnosing Osteomyelitis in Patients With Diabetic Foot Infection.

Brief Summary: This protocol will evaluate the sensitivity and specificity of [124I]FIAU as a diagnostic imaging agent for the detection of osteomyelitis in patients with diabetic foot infection.

Detailed Summary:
Sponsor: BioMed Valley Discoveries, Inc

Current Primary Outcome: Assess the Sensitivity and Specificity of [124I]FIAU PET-CT Scanning in Detecting Osteomyelitis as Determined by Bone Biopsy in Patients With Diabetic Foot Infection. [ Time Frame: 30 hours ]

A bone biopsy was obtained through a noninfected area and submitted for histology and microbiologic culture. Cultures were also to be obtained by biopsy after debridement of the ulcer from a clean base. Subjects were dosed with [124I]FIAU. PET-CT scanning were performed. All PET, PET-CT, and CT images, both attenuation corrected and uncorrected, were to be evaluated centrally and independently. Results from the bone biopsies were not available to the central reader of the PET-CT images. The sensitivity and specificity of [124I]FIAU PET-CT scanning in detecting osteomyelitis was determined based on its correlation with bone biopsy, the truth standard.


Original Primary Outcome: Assess the Sensitivity and Specificity of [124I]FIAU PET-CT Scanning in Detecting Osteomyelitis as Determined by Bone Biopsy in Patients With Diabetic Foot Infection. [ Time Frame: 30 hours ]

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


Current Secondary Outcome:

  • Assess the Safety and Tolerability of [124I]FIAU [ Time Frame: 30 +/- 2 days ]
    Safety will be monitored for all subjects for the duration of their study participation. Safety will be assessed by monitoring of adverse events,vital signs, physical exams, and clinical laboratory tests including CBC and serum chemistry.
  • Compare the Sensitivity and Specificity of [124I]FIAU PET-CT Scanning to Gadolinium-enhanced (GE) Magnetic Resonance Imaging (MRI) and Non-GE-MRI Scanning in Detecting Osteomyelitis in Patients With Diabetic Foot Infection [ Time Frame: -2 to 72 hours post dose [124I]FIAU ]
    All PET-CT images will be evaluated centrally and independently by a single radiologist. Diagnosis of osteomyelitis based on PET-CT will be compared with MRI which is currently the test of choice to diagnose osteomyelitis in diabetic foot infection.
  • Assess Any Additional Information That [124I]FIAU PET-CT Scanning Provides Compared to MRI [ Time Frame: -2 to 72 hours post dose [124I]FIAU ]
    Additional information on the extent and localization of infection will be compared to MRI.


Original Secondary Outcome: Same as current

Information By: BioMed Valley Discoveries, Inc

Dates:
Date Received: January 7, 2013
Date Started: April 2013
Date Completion:
Last Updated: April 6, 2016
Last Verified: April 2016