GE Healthcare VolumeRAD Lung Nodule Detection Study

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00963651
Study type	Observational
Source	American College of Radiology - Image Metrix
Contact
Status	Completed
Phase	N/A
Start date	August 2009
Completion date	July 2013

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT03649906` - A Clinical Study of Optimized CT-guided Pulmonary Nodule Microcoil Localization Technique	N/A
Completed	`NCT05963945` - Multi-Reader Retrospective Study Examining Carebot AI CXR 2.0.21-v2.01 Implementation in Everyday Radiology Clinical Practice
Completed	`NCT04066699` - Percutaneous Localization: Open-label Registry of Thoracic Surgery
Not yet recruiting	`NCT05477251` - Comparative Study on the Efficacy and Safety of Microwave Ablation and Lobectomy in the Treatment of Ground Glass Nodules Located in the Pulmonary Hilar Region	N/A
Completed	`NCT03591445` - Is Bronchoscopy Necessary in the Preoperative Workup of GGO Lung Cancer?(ECTOP-1005)	N/A
Withdrawn	`NCT04894682` - Safety and Long-term Effects of COVID-19 Vaccines in Patients With Pulmonary Tumor
Recruiting	`NCT03790735` - The MDA Test to Differentiate of Benign and Malignant Pulmonary Nodules
Active, not recruiting	`NCT03992183` - Utility of CAML as Diagnostic for Early Stage Lung Cancer
Recruiting	`NCT04552054` - Mixed Reality Technique Combined With 3D Printing Navigational Template for Localizing Pulmonary Nodules	N/A
Recruiting	`NCT05389774` - DOLCE: Determining the Impact of Optellum's Lung Cancer Prediction Solution
Recruiting	`NCT06308120` - A Trial to Compare Robotic Assisted Bronchoscopy Ion's Clinical Utility for Peripheral Lung Nodule Access and Diagnosis to ENB	N/A
Completed	`NCT04209972` - The Benefit of UHR-CT: Precision of Repeated Volume Measurements of Pulmonary Nodules	N/A
Completed	`NCT03181490` - Circulating Tumor DNA Methylation Test to Differentiate Benign and Malignant Pulmonary Nodules
Recruiting	`NCT05445635` - Added Value of a Small Camera (Iriscope) in the Endoscopic Diagnosis of Peripheral Lung Nodules and Masses	N/A
Recruiting	`NCT04270799` - Lung Nodule Imaging Biobank for Radiomics and AI Research
Recruiting	`NCT00841750` - Chest Tube After a Video-assisted Thoracoscopic Surgery Pulmonary Wedge Resection	Phase 3
Recruiting	`NCT05415670` - Benign/Malignant Pulmonary Nodule Classification Based on High-throughput Whole-genome Methylation Sequencing(GM-seq)
Recruiting	`NCT04005677` - The Early Diagnosis of Pulmonary Nodule Based on Multi-dimension Messages
Recruiting	`NCT05968898` - Assessment of a Radiomics-based Computer-Aided Diagnosis Tool for Pulmonary nodulES	N/A
Completed	`NCT04302350` - Nitrous Oxide for Identifying the Intersegmental Plane in Segmentectomy: A Randomized Controlled Trial	N/A