N/A
N=66
Clinical Evaluation of CARESTREAM Dual Energy and Digital Tomosynthesis
Solitary Pulmonary Nodules
Bottom Line
View on ClinicalTrials.gov: NCT02531646 ↗Enrolled (actual)
66
Serious AEs
0.0%
Results posted
Nov 2016
Primary outcome: Primary: Radlex Scale for Diagnostic Quality Ratings - DE Predicate PA Chest — 3.4540 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Radiation (Radiation)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Carestream Health, Inc.
- Primary completion
- Apr 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Radlex Scale for Diagnostic Quality Ratings - DE Predicate PA Chest |
3.4540 | — |
| PRIMARY Radlex Scale for Diagnostic Quality Ratings - DE Investigational Composite |
3.3214 | 0.000 sig |
| PRIMARY Radlex Scale for Diagnostic Quality Ratings - DE Investigational High Energy |
3.2911 | 0.000 sig |
| PRIMARY Radlex Scale for Diagnostic Quality Ratings - DE Investigational Low Energy |
3.5504 | 0.000 sig |
| PRIMARY Radlex Scale for Diagnostic Quality Ratings - DT Reference 1- PA Chest |
3.4832 | 0.000 sig |
| PRIMARY Radlex Scale for Diagnostic Quality Ratings - DT Reference 2 - PA and LAT Chest |
3.5546 | 0.007 sig |
| PRIMARY Radlex Scale for Diagnostic Quality Ratings - DT Investigational - Scout & DT Volume |
3.6277 | — |
| PRIMARY Radlex Scale for Diagnostic Quality Ratings - LT Predicate Phantom Images |
3.3494 | 0.000 sig |
| PRIMARY Radlex Scale for Diagnostic Quality Ratings - DT Investigational Phantom Images |
3.7156 | — |
Summary
The purpose of this study is to evaluate the imaging performance of Dual Energy and Digital Tomosynthesis (DE-DT) application against the commercially available predicate devices.
Eligibility Criteria
Inclusion Criteria
Age 18 years and older. Subject has provided informed consent. Study participant is scheduled to have a chest CT exam. Study participant is able to stand and be still during the exams.
Exclusion Criteria
Human subject specific:
Not able or willing to provide Informed Consent, or consent is withdrawn. Study participant is a female of child bearing age.
Data sourced from ClinicalTrials.gov (NCT02531646). 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.