GE Healthcare VolumeRAD Lung Nodule Detection Study

To perform a multiple reader, multiple case (MRMC) observer study assessing the detection performance of VolumeRAD tomosynthesis of the chest in detecting lung nodules.

Study Overview

• Status: Completed
• Conditions: Multiple Pulmonary Nodules; Pulmonary Nodule, Solitary
• Intervention / Treatment: Device: Chest tomosynthesis and X-ray

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.

• Study Type: Observational
• Enrollment (Actual): 187

Contacts and Locations

Study Locations

• Sweden
  • Gothenburg, Sweden, SE-413 45
    • Sahlgrenska University Hospital
• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48103
      • University of Michigan
  • North Carolina
    • Durham, North Carolina, United States, 27705
      • Duke University Medical Center
  • Washington
    • Seattle, Washington, United States, 98195
      • University of Washington Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Participants will include those referred for x-ray computed tomography (CT) of the chest for suspicion of a pulmonary nodule or other unrelated reasons.

Description

Inclusion Criteria:

• Scheduled for chest CT as part of their needed medical care;
• If available, individuals who have had previous imaging to suggest they fulfill the needs of the study;
• 18 years of age, or older;
• In good enough physical condition to stand motionless and hold their breath during the image acquisition procedures.

Exclusion Criteria:

• Children under 18 years of age;
• Women who are pregnant or who suspect they may be pregnant;
• Individuals who on previous imaging are shown to have objects in or around the lungs that might produce substantial artifacts that would obscure pulmonary nodules;
• Individuals who on recent imaging had active lung or pleural disease that would obscure pulmonary nodules;
• Individuals with more than 5 pulmonary nodules between 5mm and 20mm in diameter in either right or left lung.
• Individuals suspected to have more than 15 total nodules between 3mm and 20mm. NOTE that up to 20 nodules between 3mm and 20mm will be allowed in the final study sample.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Time Frame
Actionability classification accuracy of all modalities	Multipe reader, multiple case reader study

Collaborators and Investigators

• Sponsor: American College of Radiology - Image Metrix
• Collaborators: GE Healthcare
• Investigators: Principal Investigator: James Dobbins, MD, Duke University

Study record dates

Study Major Dates

• Study Start: August 1, 2009
• Primary Completion (Actual): July 1, 2013
• Study Completion (Actual): July 1, 2013

Study Registration Dates

• First Submitted: August 20, 2009
• First Submitted That Met QC Criteria: August 20, 2009
• First Posted (Estimate): August 21, 2009

Study Record Updates

• Last Update Posted (Estimate): July 24, 2013
• Last Update Submitted That Met QC Criteria: July 23, 2013
• Last Verified: July 1, 2013

More Information

Terms related to this study

• Keywords: Pulmonary nodule, solitary; Multiple pulmonary nodules
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Multiple Pulmonary Nodules; Solitary Pulmonary Nodule
• Other Study ID Numbers: GE-VORTEX; GE 2901