Testing of Computer Aided Detection Software for Riverain Medical Group

Study Overview
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Brief Summary
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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.

Detailed Description
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In 2000, data was presented to the FDA to demonstrate that a new system for computer analysis could assist radiologists in the detection of small lung cancers on chest radiographs. Radiologists using the system showed a statistically significant improvement in lung cancer detection rate when they used the system, compared to their interpretation of chest radiographs when they did not use the computer system. This study, along with other supporting data, resulted in the FDA giving Pre-Market Approval for the system. The system has undergone several improvements in software and hardware, and it is now intended to test two different software systems to determine whether radiologists using the systems can improve their detection of lung cancer on chest radiographs. One of these systems processes the chest radiograph to decrease the emphasis given to the shadow of the ribs and thereby enhances the ability of radiologists to detect disease in the lungs. The second system performs a series of evaluations on chest radiographs and, based on a complex system of analysis, points to locations on the chest radiograph that contain solitary pulmonary nodules having the characteristics of primary lung cancer or solitary metastases of cancer to the lungs. This will be a test of radiologists to determine the degree of improvement, if any, that results when they interpret chest radiographs that may or may not have cancer, first interpreted without the computer and, second, with the images output by the software.

Official Title
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Testing of Computer Aided Detection Software for Riverain Medical Group

Conditions
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Lung Cancer

Intervention / Treatment
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* Behavioral: Software


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Radiologists<br>Radiologists who have certification by the American Board of Radiology | Behavioral: Software<br>* This is an observer performance study. Radiologists will interpret chest radiographs without and then with the Riverain software, both SoftView (TM) OnGuard (TM) CADe Software with be tested<br>* Other names: OnGuard 5.1;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in Cancer Detection as Measured by Localized Receiver Operating Characteristic) LROC Changes Under the LROC Curve. | 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. | Three days of experiment over 3-5 months, varied by participant | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity and Specificity Using SoftView Software | Sensitivity and specificity were calculated using the radiologists' responses of recommendations for follow-up with CT or biopsy. Truth was whether or not the nodule identified was found to be cancer. Sensitivity is the percentage of correct identification of a positive case (a case with cancer). Specificity is the percentage of negative cases (those without cancer) that were correctly identified as not having cancer. The mean values of 15 radiologists are used. | Three days of experiment over 3-5 months, varied by participant | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lung Cancer, Chest Radiograph, Computer-aided Detection, Image processing