Reader Study of DeltaView™ Chest Radiograph Software
|ClinicalTrials.gov Identifier: NCT01261507|
Recruitment Status : Completed
First Posted : December 16, 2010
Results First Posted : July 17, 2014
Last Update Posted : December 1, 2015
|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||15 participants|
|Official 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|
|Study Start Date :||November 2010|
|Actual Primary Completion Date :||December 2011|
|Actual Study Completion Date :||December 2012|
- 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.
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01261507
|United States, District of Columbia|
|ISIS Research Center, Georgetown University Medical Center|
|Washington, District of Columbia, United States, 20007|
|Principal Investigator:||Matthew T Freedman, MD, MBA||Georgetown University|
|Principal Investigator:||S.-C. Ben Lo, PhD||Georgetown University|