GE Healthcare VolumeRAD Lung Nodule Detection Study

Pulmonary Nodule, Solitary Clinical Trial

Official title:

GE Healthcare VolumeRAD Lung Nodule Detection Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00963651
• Other study ID #: GE-VORTEX
• Secondary ID: GE 2901
• Status: Completed
• Phase: N/A
• First received: August 20, 2009
• Last updated: July 23, 2013
• Start date: August 2009
• Est. completion date: July 2013

Study information

• Verified date: July 2013
• Source: American College of Radiology - Image Metrix
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 187
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Multiple Pulmonary Nodules
• Pulmonary Nodule, Solitary
• Solitary Pulmonary Nodule

Intervention

Device:
• Chest tomosynthesis and X-ray
VolumeRAD tomosynthesis; Conventional Chest X-ray; Dual energy (bone and soft tissue PA chest images)

Locations

Country	Name	City	State
Sweden	Sahlgrenska University Hospital	Gothenburg
United States	University of Michigan	Ann Arbor	Michigan
United States	Duke University Medical Center	Durham	North Carolina
United States	University of Washington Medical Center	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
American College of Radiology - Image Metrix	GE Healthcare

Countries where clinical trial is conducted

United States,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Actionability classification accuracy of all modalities		Multipe reader, multiple case reader study	No