Testing of Computer Aided Detection Software for Riverain Medical Group

NCT00906789 | Completed Results

• 3 other identifiers: Riverain SV 2.0.1 and OG5.0Softview 2.0.1OnGuard 5.0
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Cancer

Keywords

Lung Cancer; Chest Radiograph; Computer-aided Detection; Image processing

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Sensitivity and Specificity Using SoftView Software

  Three days of experiment over 3-5 months, varied by participant

Other Outcomes (1)

• Difference in the Area Under the LROC Curve Comparing OnGuard 1.0 and OnGuard 5.1

  5 months

Study Arms (1)

Radiologists

Radiologists who have certification by the American Board of Radiology

Behavioral: Software

Interventions

Software 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

Also known as: SoftView 2.0, OnGuard 5.1

Radiologists

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• US American Board of Radiology Certified Radiologists in active clinical practice

You may not qualify if:

• 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

Sponsors & Collaborators

• Georgetown University: lead
• Riverain Technologies: collaborator

Study Sites (1)

ISIS Imaging Science Research Center, Georgetown University

Washington D.C., District of Columbia, 20057, United States

Location

Related Publications (1)

• Freedman MT, Lo SC, Seibel JC, Bromley CM. Lung nodules: improved detection with software that suppresses the rib and clavicle on chest radiographs. Radiology. 2011 Jul;260(1):265-73. doi: 10.1148/radiol.11100153. Epub 2011 Apr 14.

  PMID: 21493789 DERIVED

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Limitations and Caveats

No adverse events occurred. Study was subject to the following potential biases: Sample bias; Majority rule bias; Referral Bias, bias from knowledge that this is an experiment; reader order bias; learning bias; Bias from use of new technology, et al

Results Point of Contact

• Title: Matthew T. Freedman
• Organization: Georgetown University Medical Center

MTFreedman@verizon.net

4105429680

Study Officials

• Matthew T. Freedman, MD, MBA

  Georgetown University

  PRINCIPAL INVESTIGATOR

• Ben Lo, Ph.D.

  Georgetown University

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor Oncology, Adjunct (Pending)

Study Record Dates

• First Submitted: May 5, 2008
• First Posted: May 21, 2009
• Study Start: May 1, 2009
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: September 1, 2014
• Results First Posted: September 1, 2014

Record last verified: 2014-08

Locations

US (1)