An observational study in Pulmonary Nodule, Solitary and Multiple Pulmonary Nodules, sponsored by American College of Radiology - Image Metrix. Completed at 4 sites in 2 countries. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-07-24.
Sponsored by American College of Radiology - Image Metrix · Observational
To perform a multiple reader, multiple case (MRMC) observer study assessing the detection performance of VolumeRAD tomosynthesis of the chest in detecting lung nodules.
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.
88 studies on the registry are indexed under Solitary Pulmonary Nodule; 19 are open to participants now.
This study's enrollment of 187 is below the median of 401 across 41 observational studies indexed under Solitary Pulmonary Nodule.
Browse Solitary Pulmonary Nodule studies →American College of Radiology - Image Metrix is the lead sponsor of 2 studies on the registry; none are open to participants now.
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Participants will include those referred for x-ray computed tomography (CT) of the chest for suspicion of a pulmonary nodule or other unrelated reasons.
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Exclusion Criteria:
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)
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.
Time frame: Post accrual of 210 participants
Actionability classification accuracy of all modalities
Time frame: Multipe reader, multiple case reader study
The record gives a start of Aug 2009, a primary completion of Jul 2013 and a completion of Jul 2013. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Jul 2013. You cannot join it, but the record below documents what was studied.
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American College of Radiology - Image Metrix