N/A
N=442
Case Collection Study to Support Digital Mammography Image Software Change
Breast Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00756496 ↗Enrolled (actual)
442
Serious AEs
0.0%
Results posted
Dec 2020
Primary outcome: Primary: Area Under the Receiver Operating Characteristic (ROC) Curve to Compare Diagnostic Accuracy of 2 Algorithms in Breast Cancer Diagnosis — 0.884; 0.880 probability
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Mammography screening and diagnosis (Device)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- Female
- Sponsor
- Siemens Medical Solutions USA - CSG
- Primary completion
- Dec 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Area Under the Receiver Operating Characteristic (ROC) Curve to Compare Diagnostic Accuracy of 2 Algorithms in Breast Cancer Diagnosis |
0.884; 0.880 | — |
Summary
The primary objective of this study is to compare image processing software to support a new image processing software application for a full-field digital mammography (FFDM) system.
Eligibility Criteria
Inclusion Criteria
- Female
- > 40 years
Exclusion Criteria
- Pregnant women, or women who may become pregnant
- Mammographic evidence of breast surgery, prior radiation to the breast, needle projection or pre-biopsy markings are evident in the mammogram (but may include breast implants)
- Palpable lesion or one that is visible by another modality
- Inmates
Data sourced from ClinicalTrials.gov (NCT00756496). 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.