Back to resultsReader Study of DeltaView™ Chest Radiograph Software
Primary Purpose
Lung Neoplasm
Status
Completed
Phase
Locations
United States
Study Type
Observational
Intervention
Sponsored by
About this trial
This is an observational trial for Lung Neoplasm focused on measuring lung neoplasm nodule image processing computer-assisted
Eligibility Criteria
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
Sites / Locations
- ISIS Research Center, Georgetown University Medical Center
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
Full Information
NCT ID
NCT01261507
First Posted
December 14, 2010
Last Updated
November 4, 2015
Sponsor
Georgetown University
Collaborators
Riverain Medical Group, Miamisburg, OH, BioStat Solutions, Inc., Mt. Airy, MD
1. Study Identification
Unique Protocol Identification Number
NCT01261507
Brief Title
Reader Study of DeltaView™ Chest Radiograph Software
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 Type
Observational
2. Study Status
Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
November 2010 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Georgetown University
Collaborators
Riverain Medical Group, Miamisburg, OH, BioStat Solutions, Inc., Mt. Airy, MD
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Neoplasm
Keywords
lung neoplasm nodule image processing computer-assisted
7. Study Design
Enrollment
15 (Actual)
Primary Outcome Measure Information:
Title
Localized Receiver Operating Characteristic (LROC) Comparison
Description
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.
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Sensitivity and Specificity
Description
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.
Time Frame
1 day
Title
False Positive Decisions of Radiologists
Description
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.
Time Frame
1 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Study Population Description
Radiologists in community practice of radiology chest radiographs of individuals with or without a lung nodule
Sampling Method
Non-Probability Sample
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthew T Freedman, MD, MBA
Organizational Affiliation
Georgetown University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
S.-C. Ben Lo, PhD
Organizational Affiliation
Georgetown University
Official's Role
Principal Investigator
Facility Information:
Facility Name
ISIS Research Center, Georgetown University Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Reader Study of DeltaView™ Chest Radiograph Software
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