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GE Healthcare VolumeRAD Lung Nodule Detection Study

18 Years
Open (Enrolling)
Pulmonary Nodule, Solitary, Multiple Pulmonary Nodules

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Trial Information

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
of analysis.

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.

Type of Study:


Study Design:

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

Outcome Measure:

Multi-reader, multi-case Receiver Operating Characteristics (ROC) methodology.

Outcome Description:

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.

Outcome Time Frame:

Post accrual of 210 participants

Safety Issue:


Principal Investigator

James Dobbins, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Duke University


United States: Food and Drug Administration

Study ID:




Start Date:

August 2009

Completion Date:

June 2011

Related Keywords:

  • Pulmonary Nodule, Solitary
  • Multiple Pulmonary Nodules
  • Pulmonary nodule, solitary
  • Multiple pulmonary nodules
  • Lung Neoplasms
  • Multiple Pulmonary Nodules
  • Solitary Pulmonary Nodule



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