GE Healthcare VolumeRAD Lung Nodule Detection Study
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|ClinicalTrials.gov Identifier: NCT00963651|
Recruitment Status : Completed
First Posted : August 21, 2009
Last Update Posted : July 24, 2013
|Condition or disease||Intervention/treatment|
|Pulmonary Nodule, Solitary Multiple Pulmonary Nodules||Device: Chest tomosynthesis and X-ray|
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 software. It creates section images from a series of projection images acquired as the x-ray tube moves along a prescribed path. Because tomosynthesis can minimize the visual presence of overlying anatomy - the ribs, for example - it has the potential to improve the detection of lesions such as pulmonary nodules when compared with conventional chest radiography.
The primary aim of this study is to determine whether the use of VolumeRAD tomosynthesis, in addition to CxR, increases physician accuracy in the detection of lung nodules between 3mm and 20mm in diameter when compared to conventional posterior-anterior (PA) and lateral (LAT) chest radiography (CxR). This aim will be addressed by measuring free-response performance of experienced (with VolumeRAD), blinded expert readers' detection performance. Specifically, we will compare detection performance, as measured by the area under the alternative free response receiver operating characteristic (AFROC) curve, among readers viewing PA and LAT chest X-rays versus VolumeRAD tomosynthesis. The nodule will be the unit of analysis.
|Study Type :||Observational|
|Actual Enrollment :||187 participants|
|Official Title:||GE Healthcare VolumeRAD Lung Nodule Detection Study|
|Study Start Date :||August 2009|
|Primary Completion Date :||July 2013|
|Study Completion Date :||July 2013|
Suspicion of pulmonary nodules
Eligible participants will include those referred for x-ray computed tomography (CT) of the chest for suspicion of a pulmonary nodule or other unrelated reasons.
Device: Chest tomosynthesis and X-ray
VolumeRAD tomosynthesis; Conventional Chest X-ray; Dual energy (bone and soft tissue PA chest images)
- Multi-reader, multi-case Receiver Operating Characteristics (ROC) methodology. [ Time Frame: Post accrual of 210 participants ]The primary objective of this study is to determine if the use of VolumeRAD tomosynthesis increases the accuracy of the detection of lung nodules between 3mm and 20mm in diameter when compared to conventional PA and lateral chest radiography alone.
- Actionability classification accuracy of all modalities [ Time Frame: Multipe reader, multiple case reader study ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00963651
|United States, Michigan|
|University of Michigan|
|Ann Arbor, Michigan, United States, 48103|
|United States, North Carolina|
|Duke University Medical Center|
|Durham, North Carolina, United States, 27705|
|United States, Washington|
|University of Washington Medical Center|
|Seattle, Washington, United States, 98195|
|Sahlgrenska University Hospital|
|Gothenburg, Sweden, SE-413 45|
|Principal Investigator:||James Dobbins, MD||Duke University|