GE Healthcare VolumeRAD Lung Nodule Detection Study
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
Observational Model: Case-Only, Time Perspective: Cross-Sectional
Multi-reader, multi-case Receiver Operating Characteristics (ROC) methodology.
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.
Post accrual of 210 participants
James Dobbins, MD
United States: Food and Drug Administration
|University of Michigan||Ann Arbor, Michigan 48109-0624|
|University of Washington Medical Center||Seattle, Washington 98195-6043|
|Duke University Medical Center||Durham, North Carolina 27710|