GE Healthcare VolumeRAD Lung Nodule Detection Study

Completed

Conditions studied: Pulmonary Nodule, Solitary, Multiple Pulmonary Nodules

In brief

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

Key facts

Study ID

NCT00963651

Run by

American College of Radiology - Image Metrix

People needed

187

Starts

2009-08-01

Expected to finish

2013-07-01

Last updated by the study team

2013-07-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of Michigan — Ann Arbor, Michigan, United States
• Duke University Medical Center — Durham, North Carolina, United States
• University of Washington Medical Center — Seattle, Washington, United States
• Sahlgrenska University Hospital — Gothenburg, Sweden

Full record on ClinicalTrials.gov

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