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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
History of Changes
  Purpose

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.


Condition
Bone Mineral Density

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Bone Quality by vQCT and HR-pQCT:Translation to Multi-center Clinical Research

Resource links provided by NLM:

MedlinePlus related topics: Nuclear Scans
U.S. FDA Resources

Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 60
Study Start Date: April 2012
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Scanning
no treatment
scanning
no treatment

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   65 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Healthy men and women aged 65-80

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01544660

Contacts
Contact: isra saeed, MD 4153534922 isra.saeed@ucsf.edu

Locations
United States, California
Department of Radiology, UCSF Recruiting
San Francisco, California, United States, 94107
Contact: Thomas Lang, PhD     415-353-4552        
Sponsors and Collaborators
University of California, San Francisco
Mayo Clinic
Investigators
Principal Investigator: Thomas Lang University of California, San Francisco
  More Information

No publications provided

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01544660     History of Changes
Other Study ID Numbers: NIH-Multicenter Interscanner
Study First Received: February 14, 2012
Last Updated: May 16, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Francisco:
spine and hip scan
BMD

ClinicalTrials.gov processed this record on June 17, 2013