Bone Quality by vQCT and HR-pQCT:Translation to Multi-center Clinical Research (Interscanner)
Our overarching aim is to set up a procedural, analytic and developmental framework to establish CT of the central and peripheral skeleton as a clinically useful biomarker for skeletal strength in the clinical research and ultimately in the clinical setting. To accomplish this, the investigators will develop and validate phantoms and scanning procedures to standardize strength and structure measurements between different vQCT scanners and develop standardized acquisition, analytical, and quality control techniques for HR-pQCT with an emphasis on optimization for multi-center studies.
Bone Mineral Density
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Bone Quality by vQCT and HR-pQCT:Translation to Multi-center Clinical Research|
- Develop and Validate phantoms and scanning procedures to standardize strength and structure measurements between different scanners. [ Time Frame: one visit lasting 3 hours for each subject. ] [ Designated as safety issue: No ]Correction of the in vivo images using the proposed inter-scanner calibration approaches will improve the quality of multi-site data by reducing the variability in CT structure and strength measures. To study the Multi-center standardization of vQCT and HR-pQCT imaging we will develop new calibration phantoms to address inter and intra-scanner variability in vQCT and HRpQCT bone strength and structure estimates.
- Development of open-source image analysis metric for vQCT [ Time Frame: Time frame will be 3 hours for a visit ] [ Designated as safety issue: No ]To provide standardized analysis of future clinical studies and retrospective analysis of past trials, we will develop a set of image analysis metrics for vQCT (trabecular, cortical and integral BMD, cortical thickness, cross-sectional areas, axial and bending strength estimates). These metrics will be made available to the community in an open source format, allowing them to be incorporated into commercial software platforms at the discretion of the manufacturer, incorporation as a plug-in for NIH supported programs such as MIPAV.
|Study Start Date:||April 2012|
|Study Completion Date:||March 2014|
|Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
The investigators will develop new calibration phantoms to address inter and intra scanner variability in vQCT and HRpQCT. Phantom sets to evaluate inter-scanner disparity and determine corrections to apply to in vivo scan data in the multi-center settings. These methods will be validated in a multi-center phantom study and in a 120 patients
Please refer to this study by its ClinicalTrials.gov identifier: NCT01544660
|United States, California|
|Department of Radiology, UCSF|
|San Francisco, California, United States, 94107|
|Principal Investigator:||Thomas Lang||University of California, San Francisco|