NCT00963651

GE Healthcare VolumeRAD Lung Nodule Detection Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 187 (actual)
• Sponsor: American College of Radiology - Image Metrix · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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 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.

Conditions

• Pulmonary Nodule, Solitary
• Multiple Pulmonary Nodules

Interventions

Type	Name	Description
DEVICE	Chest tomosynthesis and X-ray	VolumeRAD tomosynthesis; Conventional Chest X-ray; Dual energy (bone and soft tissue PA chest images)

Timeline

• Start date: 2009-08-01
• Primary completion: 2013-07-01
• Completion: 2013-07-01
• First posted: 2009-08-21
• Last updated: 2013-07-24

Locations

4 sites across 2 countries: United States, Sweden