Reader Study of DeltaView™ Chest Radiograph Software

NCT01261507 | Completed Results

• 1 other identifier: DHF-183-0531A
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Neoplasm

Keywords

lung neoplasm nodule image processing computer-assisted

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Sensitivity and Specificity

  1 day

• False Positive Decisions of Radiologists

  1 day

Eligibility Criteria

• Age: 35 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• Radiologists who assisted by providing cases for review
• For chest radiographs: poor image quality

Sponsors & Collaborators

• Georgetown University: lead
• Riverain Medical Group, Miamisburg, OH: collaborator
• BioStat Solutions, Inc., Mt. Airy, MD: collaborator

Study Sites (1)

ISIS Research Center, Georgetown University Medical Center

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

Location

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

The main limitation is that the experimental format for this study is similar to, but not identical to the clinical pattern of practice in that more data is recorded during the study than would normally be gathered in clinical practice

Results Point of Contact

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

freedmmt@georgetown.edu

4105429680

Study Officials

• Matthew T Freedman, MD, MBA

  Georgetown University

  PRINCIPAL INVESTIGATOR

• S.-C. Ben Lo, PhD

  Georgetown University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor Oncology

Study Record Dates

• First Submitted: December 14, 2010
• First Posted: December 16, 2010
• Study Start: November 1, 2010
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2012
• Last Updated: December 1, 2015
• Results First Posted: July 17, 2014

Record last verified: 2015-11

Locations

US (1)