N/A
N=16
Efficacy of Digital Breast Tomosynthesis + Standard 2- Dimensional Mammography in Breast Cancer
Breast Cancer
Bottom Line
View on ClinicalTrials.gov: NCT03190083 ↗Enrolled (actual)
16
Serious AEs
0.0%
Results posted
Apr 2020
Primary outcome: Primary: Number of Participants for Which DBT Altered Surgical Plan — 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- 2-dimensional mammogram (Device); digital breast tomosynthesis (DBT) (Device)
- Age
- Adult, Older Adult · 25+ yrs
- Sex
- Female
- Sponsor
- Case Comprehensive Cancer Center
- Primary completion
- Jun 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants for Which DBT Altered Surgical Plan |
— | — |
Summary
The purpose of this study is to determine if a 3-dimensional mammogram (DBT) may provide additional information to evaluate the extent of disease and additional findings that would aid in staging a new breast cancer patient. This would impact surgical planning and improve patient outcomes.
Eligibility Criteria
Inclusion Criteria
- New diagnosis of breast cancer
- New diagnosis if a previous breast cancer patient with negative surgical margins
- Patients willing to sign a written informed consent form
Exclusion Criteria
- High risk benign lesions as the primary pathology diagnosis
Data sourced from ClinicalTrials.gov (NCT03190083). 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.