N/A
N=496
Breast Cancer Detection: Comparison of Breast Tomosynthesis and Conventional Mammography
Breast Cancer
Bottom Line
View on ClinicalTrials.gov: NCT01669148 ↗Enrolled (actual)
496
Serious AEs
—
Results posted
Jun 2017
Primary outcome: Primary: Detection of Breast Cancer (Sensitivity)
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Tomosynthesis (Device); Conventional (Device)
- Age
- Adult, Older Adult · 35+ yrs
- Sex
- Female
- Sponsor
- Massachusetts General Hospital
- Primary completion
- Jun 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Detection of Breast Cancer (Sensitivity) |
— | — |
Summary
The primary hypothesis to be tested is:
The detection of breast cancer will be increased with tomosynthesis (3D) imaging
Eligibility Criteria
Inclusion Criteria
- Female
- Any ethnic origin
- No contraindication for routine bilateral mammography
Exclusion Criteria
Potential subjects with any of the following will not be enrolled in the study:
- Any contraindications to mammographic screening, including, but not limited to:
- Significant existing breast trauma
- Under the age of 30 at the time of consent
- Breast Implants
- Prior Surgeries
- Unable to understand and execute written informed consent
- Pregnant
- Lactating
Data sourced from ClinicalTrials.gov (NCT01669148). 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.