Ignite Creation Date:
2025-12-25 @ 2:02 AM
Ignite Modification Date:
2026-01-07 @ 5:45 PM
Study NCT ID:
NCT01544660
Status:
COMPLETED
Last Update Posted:
2014-04-16
First Post:
2012-02-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bone Quality by vQCT and HR-pQCT:Translation to Multi-center Clinical Research
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-04', 'completionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-04-15', 'studyFirstSubmitDate': '2012-02-14', 'studyFirstSubmitQcDate': '2012-03-05', 'lastUpdatePostDateStruct': {'date': '2014-04-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-03-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Develop and Validate phantoms and scanning procedures to standardize strength and structure measurements between different scanners.', 'timeFrame': 'one visit lasting 3 hours for each subject.', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Development of open-source image analysis metric for vQCT', 'timeFrame': 'Time frame will be 3 hours for a visit', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['spine and hip scan', 'BMD'], 'conditions': ['Bone Mineral Density']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '65 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Healthy men and women aged 65-80', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy men and women\n* must be able to lie down on bed\n\nExclusion Criteria:\n\n* on wheel chair\n* age above 80 years 0r less than 65 years'}, 'identificationModule': {'nctId': 'NCT01544660', 'acronym': 'Interscanner', 'briefTitle': 'Bone Quality by vQCT and HR-pQCT:Translation to Multi-center Clinical Research', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Francisco'}, 'officialTitle': 'Bone Quality by vQCT and HR-pQCT:Translation to Multi-center Clinical Research', 'orgStudyIdInfo': {'id': 'NIH-Multicenter Interscanner'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Scanning', 'description': 'no treatment'}, {'label': 'scanning', 'description': 'no treatment'}]}, 'contactsLocationsModule': {'locations': [{'zip': '94107', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'Department of Radiology, UCSF', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}], 'overallOfficials': [{'name': 'Thomas Lang', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Francisco'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Francisco', 'class': 'OTHER'}, 'collaborators': [{'name': 'Mayo Clinic', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}