Reader Study of DeltaView™ Chest Radiograph Software
This study is ongoing, but not recruiting participants.
Sponsor:
Georgetown University
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
| Tracking Information | |||||||||
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| First Received Date ICMJE | December 14, 2010 | ||||||||
| Last Updated Date | March 12, 2012 | ||||||||
| Start Date ICMJE | November 2010 | ||||||||
| Primary Completion Date | December 2011 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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 |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01261507 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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. |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Reader Study of DeltaView™ Chest Radiograph Software | ||||||||
| Official Title ICMJE | Reader Study to Demonstrate That Use of DeltaView™ is Superior to the Use Standard Prior and Current AP/PA X-ray Image Pair | ||||||||
| 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. |
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| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Not Provided | ||||||||
| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Not Provided | ||||||||
| Sampling Method | Non-Probability Sample | ||||||||
| Study Population | Radiologists in community practice of radiology chest radiographs of individuals with or without a lung nodule |
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| Condition ICMJE | Lung Neoplasm | ||||||||
| Intervention ICMJE | Not Provided | ||||||||
| Study Group/Cohort (s) | Not Provided | ||||||||
| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Active, not recruiting | ||||||||
| Estimated Enrollment ICMJE | 10 | ||||||||
| Estimated Completion Date | December 2012 | ||||||||
| Primary Completion Date | December 2011 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | 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 |
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| Gender | Both | ||||||||
| Ages | 35 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01261507 | ||||||||
| Other Study ID Numbers ICMJE | DHF-183-0531A | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Matthew T. Freedman, MD, Georgetown University | ||||||||
| Study Sponsor ICMJE | Georgetown University | ||||||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| Information Provided By | Georgetown University | ||||||||
| Verification Date | March 2012 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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