GE Healthcare VolumeRAD Lung Nodule Detection Study

This study has been completed.
Sponsor:
Collaborator:
GE Healthcare
Information provided by (Responsible Party):
American College of Radiology - Image Metrix
ClinicalTrials.gov Identifier:
NCT00963651
First received: August 20, 2009
Last updated: July 23, 2013
Last verified: July 2013
  Purpose

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


Condition Intervention
Pulmonary Nodule, Solitary
Multiple Pulmonary Nodules
Device: Chest tomosynthesis and X-ray

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: GE Healthcare VolumeRAD Lung Nodule Detection Study

Resource links provided by NLM:


Further study details as provided by American College of Radiology - Image Metrix:

Primary Outcome Measures:
  • Multi-reader, multi-case Receiver Operating Characteristics (ROC) methodology. [ Time Frame: Post accrual of 210 participants ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Actionability classification accuracy of all modalities [ Time Frame: Multipe reader, multiple case reader study ] [ Designated as safety issue: No ]

Enrollment: 187
Study Start Date: August 2009
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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)

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00963651

Locations
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48103
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27705
United States, Washington
University of Washington Medical Center
Seattle, Washington, United States, 98195
Sweden
Sahlgrenska University Hospital
Gothenburg, Sweden, SE-413 45
Sponsors and Collaborators
American College of Radiology - Image Metrix
GE Healthcare
Investigators
Principal Investigator: James Dobbins, MD Duke University
  More Information

No publications provided

Responsible Party: American College of Radiology - Image Metrix
ClinicalTrials.gov Identifier: NCT00963651     History of Changes
Other Study ID Numbers: GE-VORTEX, GE 2901
Study First Received: August 20, 2009
Last Updated: July 23, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by American College of Radiology - Image Metrix:
Pulmonary nodule, solitary
Multiple pulmonary nodules

Additional relevant MeSH terms:
Lung Neoplasms
Multiple Pulmonary Nodules
Solitary Pulmonary Nodule
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on April 16, 2014