Testing of Computer Aided Detection Software for Riverain Medical Group

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

15 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-05-31

Study Completion Date

2010-06-30

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.

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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.

Conditions

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Lung Cancer

Study Groups

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Radiologists

Radiologists who have certification by the American Board of Radiology

Software

Intervention Type BEHAVIORAL

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

Interventions

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Software

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

Intervention Type BEHAVIORAL

Other Intervention Names

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SoftView 2.0 OnGuard 5.1

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

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes