Working... Menu

Testing of Computer Aided Detection Software for Riverain Medical Group

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00906789
Recruitment Status : Completed
First Posted : May 21, 2009
Results First Posted : September 1, 2014
Last Update Posted : September 1, 2014
Riverain Technologies
Information provided by (Responsible Party):
Matthew T. Freedman, MD, Georgetown University

Brief Summary:
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.

Condition or disease Intervention/treatment
Lung Cancer Behavioral: Software

Detailed Description:

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.

Layout table for study information
Study Type : Observational
Actual Enrollment : 15 participants
Official Title: Testing of Computer Aided Detection Software for Riverain Medical Group
Study Start Date : May 2009
Actual Primary Completion Date : June 2010
Actual Study Completion Date : June 2010

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
Radiologists who have certification by the American Board of Radiology
Behavioral: 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
Other Names:
  • SoftView 2.0
  • OnGuard 5.1

Primary Outcome Measures :
  1. Improvement in Cancer Detection as Measured by Localized Receiver Operating Characteristic) LROC Changes Under the LROC Curve. [ Time Frame: Three days of experiment over 3-5 months, varied by participant ]

    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.

Secondary Outcome Measures :
  1. Sensitivity and Specificity Using SoftView Software [ Time Frame: Three days of experiment over 3-5 months, varied by participant ]
    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.

Other Outcome Measures:
  1. Difference in the Area Under the LROC Curve Comparing OnGuard 1.0 and OnGuard 5.1 [ Time Frame: 5 months ]
    This reports the comparison of the detection of lung nodules that were proven to represent lung cancers. It compares the results of two versions of computer-aided detection software: OnGuard 1.0 from 2001 and OnGuard 5.1 from 2009. The results represent the responses of radiologists when they use one or the other types of software. To compare radiologists' results with the two types of software, the measurement analyzed was the difference in the areas under the localized receiver operating characteristic curve (LROC). The results from the 15 participating radiologists were averaged (mean value). The area under the LROC curve is a measure of the trade-offs between sensitivity and 1-specificity that occurs as the level of certainty of a positive finding changes. It is normally reported as a decimal without units. In this study dsign, a lower number indicates that the new method (OnGuard 5.1), if statistically significant, if better.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Radiologists in active clinical practice who are not subspecialists in chest radiology

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00906789

Layout table for location information
United States, District of Columbia
ISIS Imaging Science Research Center, Georgetown University
Washington, District of Columbia, United States, 20057
Sponsors and Collaborators
Georgetown University
Riverain Technologies
Layout table for investigator information
Principal Investigator: Matthew T. Freedman, MD, MBA Georgetown University
Study Director: Ben Lo, Ph.D. Georgetown University

Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Matthew T. Freedman, MD, Associate Professor Oncology, Adjunct (Pending), Georgetown University Identifier: NCT00906789     History of Changes
Other Study ID Numbers: Riverain SV 2.0.1 and OG5.0
Softview 2.0.1 ( Other Grant/Funding Number: Riverain Medical Group )
OnGuard 5.0 ( Other Grant/Funding Number: Riverain Medical Group )
First Posted: May 21, 2009    Key Record Dates
Results First Posted: September 1, 2014
Last Update Posted: September 1, 2014
Last Verified: August 2014

Keywords provided by Matthew T. Freedman, MD, Georgetown University:
Lung Cancer
Chest Radiograph
Computer-aided Detection
Image processing

Additional relevant MeSH terms:
Layout table for MeSH terms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases