Clinical trial · Observational
Reader Study of DeltaView™ Chest Radiograph Software
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
NCT01261507CI-TRIAL-00019981completedResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Neoplasm | Lung Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Localized Receiver Operating Characteristic (LROC) Comparison
- timeFrame
- 1 day
- 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.
Secondary outcomes (2)
- measure
- Sensitivity and Specificity
- timeFrame
- 1 day
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 35 Years
- Maximum age
- 100 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.