Clinical trial · Observational
GE Healthcare VolumeRAD Lung Nodule Detection Study
NCT00963651CI-TRIAL-00011457completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To perform a multiple reader, multiple case (MRMC) observer study assessing the detection performance of VolumeRAD tomosynthesis of the chest in detecting lung nodules.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Multiple Pulmonary Nodules | — | UNRESOLVED | — |
| Pulmonary Nodule, Solitary | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Chest tomosynthesis and X-ray | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Suspicion of pulmonary nodules
- description
- 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.
- interventionNames
- Device: Chest tomosynthesis and X-ray
Primary outcomes (1)
- measure
- Multi-reader, multi-case Receiver Operating Characteristics (ROC) methodology.
- timeFrame
- Post accrual of 210 participants
- description
- 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 outcomes (1)
- measure
- Actionability classification accuracy of all modalities
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.