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.

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Key information

Conditions

Bone Mineral Density

Age range

65 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Radiology, UCSF

San Francisco, California, 94107, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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.

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 outcomes

Development of open-source image analysis metric for vQCT

Time frame: Time frame will be 3 hours for a visit

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.

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

Mayo Clinic

Registry information

Acronym: Interscanner

Important dates

Study start: 2012
Primary completion: 2013
Study completion: 2014
First posted: Mar 6, 2012
Registry last updated: Apr 16, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed