Clinical trial NCT00963651: GE Healthcare VolumeRAD Lung Nodule Detection Study
Official title: GE Healthcare VolumeRAD Lung Nodule Detection Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Nodule, Solitary
Multiple Pulmonary Nodules
Keywords: Pulmonary nodule, solitary
Multiple pulmonary nodules
Lead sponsor: American College of Radiology - Image Metrix
Sponsor class: INDUSTRY
Collaborators: name: GE Healthcare
First posted: 2009-08-21
Enrollment: 187
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
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.

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 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Multi-reader, multi-case Receiver Operating Characteristics (ROC) methodology.
timeFrame: Post accrual of 210 participants
Secondary outcomes:
measure: Actionability classification accuracy of all modalities
timeFrame: Multipe reader, multiple case reader study
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Seattle
country: United States
facility: University of Washington Medical Center
state: Washington
city: Gothenburg
country: Sweden
facility: Sahlgrenska University Hospital
Study officials:
affiliation: Duke University
name: James Dobbins, MD
role: PRINCIPAL_INVESTIGATOR
References: