Bone Quality by vQCT and HR-pQCT:Translation to Multi-center Clinical Research (Interscanner)

This study is currently recruiting participants.
Verified May 2013 by University of California, San Francisco
Sponsor:
Collaborator:
Mayo Clinic
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01544660
First received: February 14, 2012
Last updated: May 16, 2013
Last verified: May 2013

February 14, 2012
May 16, 2013
April 2012
December 2013   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01544660 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
Bone Quality by vQCT and HR-pQCT:Translation to Multi-center Clinical Research
Bone Quality by vQCT and HR-pQCT:Translation to Multi-center Clinical Research

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.

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

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Healthy men and women aged 65-80

Bone Mineral Density
Not Provided
  • Scanning
    no treatment
  • scanning
    no treatment
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
March 2014
December 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Healthy men and women
  • must be able to lie down on bed

Exclusion Criteria:

  • on wheel chair
  • age above 80 years 0r less than 65 years
Both
65 Years to 80 Years
Yes
Contact: isra saeed, MD 4153534922 isra.saeed@ucsf.edu
United States
 
NCT01544660
NIH-Multicenter Interscanner
No
University of California, San Francisco
University of California, San Francisco
Mayo Clinic
Principal Investigator: Thomas Lang University of California, San Francisco
University of California, San Francisco
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP