Reader Study of DeltaView™ Chest Radiograph Software

Reader Study to Demonstrate That Use of DeltaView™ is Superior to the Use Standard Prior and Current Antero/Posterior (AP/PA) X-ray Image Pair

A new software product takes two chest radiographs, aligns them, and then subtracts one image from the other. The resulting image represents an image showing any differences between them. The study is to determine whether radiologists using this new software perform better with it than when they do not use it.

Study Overview

• Status: Completed
• Conditions: Lung Neoplasm

• Study Type: Observational
• Enrollment (Actual): 15

Contacts and Locations

Study Locations

• United States
  • District of Columbia
    • Washington, District of Columbia, United States, 20007
      • ISIS Research Center, Georgetown University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Radiologists in community practice of radiology chest radiographs of individuals with or without a lung nodule

Description

Inclusion Criteria:

For Radiologists: American Board of Radiology Certification and live within the Baltimore, MD-Washington, DC Metropolitan areas

For chest radiographs, evidence of the presence or absence of lung nodule confirmed by expert panel; adequate image quality

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Exclusion Criteria:

Radiologists who assisted by providing cases for review

For chest radiographs: poor image quality

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Localized Receiver Operating Characteristic (LROC) Comparison	The area under the LROC curve will be compared for the chest radiograph interpretations done without the new software and those done with the new software. Improvement will be demonstrated if the improvement with the new software is statistically significant at the p=<0.05. There were 422 cases in the total study. 20 of these were inserted as "noise" cases, not to be analyzed. Thus there were 402 cases to be analyzed. There were 120 cases with nodules and 282 without a nodule. LROC is a method for measuring the success or failure of a method where there is a tradeoff between the detection of lung nodules that are there (true positives) and the detection that the radiologist considers to be a nodule where no nodule is present (false positive). It yields a single number that done not have a unit of measurement.	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity and Specificity	Sensitivity and specificity will be measured. If the radiologists using the new software have higher sensitivity, statistically significant at the p=< 0.05, the use of the new software will be considered to have resulted in improvement. A decrease in specificity is expected.	1 day
False Positive Decisions of Radiologists	This is a comparison of the radiologists working without and with the software. The false positive rate is the percentage of cases in which the radiologists identified a lesions/location suspected of being cancer at a location where cancer was not present. . A false positive represents a location selected on a chest image without cancer and, also, a mark on a chest image where cancer was present, but a different location, one without cancer, was marked.The radiologists could mark up to five locations on an image and had to provide a confidence rating for each. This analysis is of the single mark with the highest confidence level.	1 day

Collaborators and Investigators

• Sponsor: Georgetown University
• Collaborators: Riverain Medical Group, Miamisburg, OH; BioStat Solutions, Inc., Mt. Airy, MD
• Investigators: Principal Investigator: Matthew T Freedman, MD, MBA, Georgetown University; Principal Investigator: S.-C. Ben Lo, PhD, Georgetown University

Study record dates

Study Major Dates

• Study Start: November 1, 2010
• Primary Completion (Actual): December 1, 2011
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: December 14, 2010
• First Submitted That Met QC Criteria: December 15, 2010
• First Posted (Estimate): December 16, 2010

Study Record Updates

• Last Update Posted (Estimate): December 1, 2015
• Last Update Submitted That Met QC Criteria: November 4, 2015
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Keywords: lung neoplasm nodule image processing computer-assisted
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: DHF-183-0531A