Status:
COMPLETED
GE Healthcare VolumeRAD Lung Nodule Detection Study
Lead Sponsor:
American College of Radiology - Image Metrix
Collaborating Sponsors:
GE Healthcare
Conditions:
Pulmonary Nodule, Solitary
Multiple Pulmonary Nodules
Eligibility:
All Genders
18+ years
Brief Summary
To perform a multiple reader, multiple case (MRMC) observer study assessing the detection performance of VolumeRAD tomosynthesis of the chest in detecting lung nodules.
Detailed Description
Digital tomosynthesis is a form of limited angle tomography that creates a series of section images using a conventional x-ray tube and generator, a digital detector, and appropriate reconstruction so...
Eligibility Criteria
Inclusion
- Scheduled for chest CT as part of their needed medical care;
- If available, individuals who have had previous imaging to suggest they fulfill the needs of the study;
- 18 years of age, or older;
- In good enough physical condition to stand motionless and hold their breath during the image acquisition procedures.
Exclusion
- Children under 18 years of age;
- Women who are pregnant or who suspect they may be pregnant;
- Individuals who on previous imaging are shown to have objects in or around the lungs that might produce substantial artifacts that would obscure pulmonary nodules;
- Individuals who on recent imaging had active lung or pleural disease that would obscure pulmonary nodules;
- Individuals with more than 5 pulmonary nodules between 5mm and 20mm in diameter in either right or left lung.
- Individuals suspected to have more than 15 total nodules between 3mm and 20mm. NOTE that up to 20 nodules between 3mm and 20mm will be allowed in the final study sample.
Key Trial Info
Start Date :
August 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 1 2013
Estimated Enrollment :
187 Patients enrolled
Trial Details
Trial ID
NCT00963651
Start Date
August 1 2009
End Date
July 1 2013
Last Update
July 24 2013
Active Locations (4)
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1
University of Michigan
Ann Arbor, Michigan, United States, 48103
2
Duke University Medical Center
Durham, North Carolina, United States, 27705
3
University of Washington Medical Center
Seattle, Washington, United States, 98195
4
Sahlgrenska University Hospital
Gothenburg, Sweden, SE-413 45