Clinical Trial: GE Healthcare VolumeRAD Lung Nodule Detection Study

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: GE Healthcare VolumeRAD Lung Nodule Detection Study

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 Summary:

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.


Sponsor: American College of Radiology - Image Metrix

Current Primary Outcome: 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.


Original Primary Outcome: Multi-reader, multi-case Receiver Operating Characteristics (ROC) methodology. [ Time Frame: Post accrual of 210 participants ]

Current Secondary Outcome: Actionability classification accuracy of all modalities [ Time Frame: Multipe reader, multiple case reader study ]

Original Secondary Outcome: Same as current

Information By: American College of Radiology - Image Metrix

Dates:
Date Received: August 20, 2009
Date Started: August 2009
Date Completion:
Last Updated: July 23, 2013
Last Verified: July 2013