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Completed

NCT Number: NCT01261507

Reader Study of DeltaView™ Chest Radiograph Software

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.

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Key information

Conditions

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

Age range

35 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

ISIS Research Center, Georgetown University Medical Center

Washington D.C., District of Columbia, 20007, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

-

Exclusion criteria

Radiologists who assisted by providing cases for review

For chest radiographs: poor image quality

Treatment and study plan

Primary outcomes

  1. Localized Receiver Operating Characteristic (LROC) Comparison

    Time frame: 1 day

    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.

Secondary outcomes

  1. Sensitivity and Specificity

    Time frame: 1 day

    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.

  2. False Positive Decisions of Radiologists

    Time frame: 1 day

    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.

Sponsors and collaborators

Lead sponsor

Georgetown University

Other

Collaborators

  • BioStat Solutions, Inc., Mt. Airy, MD
  • Riverain Medical Group, Miamisburg, OH

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2011
Study completion
2012
First posted
Dec 16, 2010
Registry last updated
Dec 1, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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