N/A
Completed N=15
Reader Study of DeltaView™ Chest Radiograph Software
Source: ClinicalTrials.gov NCT01261507 ↗Enrolled (actual)
15
Serious AEs
0.0%
Results posted
Jul 2014
Primary outcomePrimary: Localized Receiver Operating Characteristic (LROC) Comparison — 0.477; 0.536 unitless — p=<0.05
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Localized Receiver Operating Characteristic (LROC) Comparison |
0.477; 0.536 | <0.05 sig |
| SECONDARY Sensitivity and Specificity |
43.8; 50.1; 94.1; 92.6 | — |
| SECONDARY False Positive Decisions of Radiologists |
9.7; 11.2 | — |
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
Data sourced from ClinicalTrials.gov (NCT01261507). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.