[124I]FIAU PET-CT Scanning in Diagnosing Osteomyelitis in Patients With Diabetic Foot Infection
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01764919|
Recruitment Status : Terminated (No correlation between FIAU uptake and bone biopsy results.)
First Posted : January 10, 2013
Results First Posted : April 8, 2016
Last Update Posted : April 8, 2016
|Condition or disease||Intervention/treatment||Phase|
|Diabetic Foot Infection||Radiation: [124I]FIAU||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||4 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Exploration of the Use of [124I]FIAU Positron Emission Tomography-Computed Tomography Scanning in Diagnosing Osteomyelitis in Patients With Diabetic Foot Infection.|
|Study Start Date :||April 2013|
|Actual Primary Completion Date :||July 2013|
|Actual Study Completion Date :||February 2014|
Single intravenous injection of [124I]FIAU in patients with diabetic foot infection
A single intravenous injection of 5 mCi[124I]FIAU in patients with diabetic foot infection who will undergo 2 PET-CT scanning.
- 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.
- 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.
- Explore the Performance of [124I]FIAU PET-CT Compared to MRI in Detecting Osteomyelitis by Chronic Kidney Disease (CKD) Stage (Stage 1+2, Stage 3, and Stage 4+5). [ Time Frame: -2 hours to 72 hours post dose [124I]FIAU ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01764919
|United States, Arizona|
|The University of Arizona|
|Tucson, Arizona, United States, 85724|
|United States, Arkansas|
|University of Arkansas for Medical Sciences|
|Little Rock, Arkansas, United States, 72205|
|United States, Pennsylvania|
|University of Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104|