Clinical trial · Observational
Testing of Computer Aided Detection Software for Riverain Medical Group
NCT00906789CI-TRIAL-00015518completedResults postedClinicalTrials.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)
This is a clinical trial using retrospective data of two different software devices developed by Riverain Medical Group: Softview and OnGuard 5.0. The two studies will be run concurrently. Riverain Medical Group's computer systems are designed to assist radiologists in their identification of lung cancer on chest radiographs. The current machine received FDA Pre-Market Approval. This is to test two new software approaches.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Software | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Radiologists
- description
- Radiologists who have certification by the American Board of Radiology
- interventionNames
- Behavioral: Software
Primary outcomes (1)
- measure
- Improvement in Cancer Detection as Measured by Localized Receiver Operating Characteristic) LROC Changes Under the LROC Curve.
- timeFrame
- Three days of experiment over 3-5 months, varied by participant
- description
- Standard methods for LROC methodology and statistical analysis were used. We are testing two different types of software using different cases, but the same radiologists to control for radiologist differences. LROC is Localized Receiver Operating Characteristic. LROC measures the trade-offs between sensitivity and specificity as radiologists use different levels of suspicion of disease. This analysis is for the software that decreases the visibility of the ribs and clavicles while preserving (and potentially enhancing) the visibility of the lungs and lung diseases. In this case, the level of suspicion recorded was for the radiologist's concern that a finding did or did not represent cancer. Please note that the FDA approved indications for use is to detected nodules that may represent cancer, but in our study scoring for a true finding was based on whether or not the nodule did represent cancer. A larger number, if statistically significant, indicates that that method is better.
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: * US American Board of Radiology Certified Radiologists in active clinical practice Exclusion Criteria: * Specialists in pulmonary or chest or cardio-pulmonary radiology Prior membership on expert panels for this study who prepared cases Current or recent colleagues or trainees (within 10 years) of the Principal Investigator
References
Publications (1)
- DERIVEDFreedman MT, Lo SC, Seibel JC, Bromley CM. Lung nodules: improved detection with software that suppresses the rib and clavicle on chest radiographs. Radiology. 2011 Jul;260(1):265-73. doi: 10.1148/radiol.11100153. Epub 2011 Apr 14. PMID 21493789