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Reader Study of DeltaView™ Chest Radiograph Software

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Riverain Medical Group, Miamisburg, OH
BioStat Solutions, Inc., Mt. Airy, MD
Information provided by (Responsible Party):
Matthew T. Freedman, MD, Georgetown University
ClinicalTrials.gov Identifier:
NCT01261507
First received: December 14, 2010
Last updated: March 12, 2012
Last verified: March 2012
History of Changes
  Purpose

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.


Condition
Lung Neoplasm

Study Type: Observational
Official Title: Reader Study to Demonstrate That Use of DeltaView™ is Superior to the Use Standard Prior and Current AP/PA X-ray Image Pair

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Georgetown University:

Primary Outcome Measures:
  • LROC comparison [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • Sensitivity and Specificity [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 10
Study Start Date: November 2010
Estimated Study Completion Date: December 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   35 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01261507

Locations
United States, District of Columbia
ISIS Research Center, Georgetown University Medical Center
Washington, District of Columbia, United States, 20007
Sponsors and Collaborators
Georgetown University
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
  More Information

No publications provided

Responsible Party: Matthew T. Freedman, MD, Associate Professor Oncology, Georgetown University
ClinicalTrials.gov Identifier: NCT01261507     History of Changes
Other Study ID Numbers: DHF-183-0531A
Study First Received: December 14, 2010
Last Updated: March 12, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Georgetown University:
lung neoplasm nodule image processing computer-assisted

Additional relevant MeSH terms:
Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
 Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on June 17, 2013