Testing of Computer Aided Detection Software for Riverain Medical Group

This study has been completed.
Sponsor:
Collaborator:
Riverain Technologies, Inc
Information provided by (Responsible Party):
Matthew T. Freedman, MD, Georgetown University
ClinicalTrials.gov Identifier:
NCT00906789
First received: May 5, 2008
Last updated: August 20, 2014
Last verified: August 2014
  Purpose

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 Intervention
Lung Cancer
Behavioral: Software

Study Type: Observational
Official Title: Testing of Computer Aided Detection Software for Riverain Medical Group

Resource links provided by NLM:


Further study details as provided by Georgetown University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

    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:
  • Sensitivity and Specificity Using SoftView Software [ Time Frame: Three days of experiment over 3-5 months, varied by participant ] [ Designated as safety issue: No ]
    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:
  • Difference in the Area Under the LROC Curve Comparing OnGuard 1.0 and OnGuard 5.1 [ Time Frame: 5 months ] [ Designated as safety issue: No ]
    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.


Enrollment: 15
Study Start Date: May 2009
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Radiologists
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

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Radiologists in active clinical practice who are not subspecialists in chest radiology

Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00906789

Locations
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, Inc
Investigators
Principal Investigator: Matthew T. Freedman, MD, MBA Georgetown University
Study Director: Ben Lo, Ph.D. Georgetown University
  More Information

No publications provided by Georgetown University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Matthew T. Freedman, MD, Associate Professor Oncology, Adjunct (Pending), Georgetown University
ClinicalTrials.gov Identifier: NCT00906789     History of Changes
Other Study ID Numbers: Riverain SV 2.0.1 and OG5.0, Softview 2.0.1, OnGuard 5.0
Study First Received: May 5, 2008
Results First Received: September 19, 2013
Last Updated: August 20, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Georgetown University:
Lung Cancer
Chest Radiograph
Computer-aided Detection
Image processing

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

ClinicalTrials.gov processed this record on September 30, 2014