Testing of Computer Aided Detection Software for Riverain Medical Group

This study has been completed.
Sponsor:
Information provided by:
Georgetown University
ClinicalTrials.gov Identifier:
NCT00906789
First received: May 5, 2008
Last updated: July 13, 2010
Last verified: July 2010
  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: Riverain OnGuard CAD 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 ROC methodology [ Time Frame: Three days of experiment over 3-5 months ] [ Designated as safety issue: Yes ]

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: Riverain OnGuard CAD 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
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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
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, MBA, Lombardi Comprehensive Cancer Center, 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
Last Updated: July 13, 2010
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 August 01, 2014