Efficacy of Digital Breast Tomosynthesis + Standard 2- Dimensional Mammography in Breast Cancer

Not Applicable

Completed

Interventions: Device: 2-dimensional mammogram
Device: digital breast tomosynthesis (DBT)

Brief 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.

Detailed Description: Primary Objective:

The primary objective of the study is to measure the frequency with which DBT alters the surgical plan to mastectomy versus lumpectomy. Only positive findings, like an additional site of cancer or DCIS, will be taken into account when estimating the frequency of changes to surgical management.

Secondary objectives:

1. To measure the frequency and nature of additional findings like atypical pathology (Atypical ductal/ lobular hyperplasia, papilloma, Lobular carcinoma in situ (LCIS) , requiring surgical intervention).

2. To identify variables on 2D (e.g. dense breasts, architectural distortions, non calcified masses) that might predict which patients would benefit from DBT.

3. To measure the proportion of patients undergoing additional work-up following the DBT, and the subset of these patients with benign findings (i.e. False Positives).

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
3-dimensional tomosynthesis mammogram	digital breast tomosynthesis (DBT)	The patients assigned a Breast imaging-reporting and data system (BIRADS) 5 category at the time of diagnosis and all new diagnosed breast cancer patients, will undergo a separate 2-D plus DBT in addition to the standard 2-D mammogram
3-dimensional tomosynthesis mammogram	2-dimensional mammogram	The patients assigned a Breast imaging-reporting and data system (BIRADS) 5 category at the time of diagnosis and all new diagnosed breast cancer patients, will undergo a separate 2-D plus DBT in addition to the standard 2-D mammogram

Primary Outcome Measures

Name	Time	Method
Number of Participants for Which DBT Altered Surgical Plan	At completion of 3-Dimensional mammogram (1 day)	Only positive findings, like an additional site of cancer or atypical pathology like Atypical ductal/ lobular hyperplasia, papilloma, DCIS/LCIS (findings requiring surgical intervention), will be taken into account when estimating the frequency of changes to surgical management

Secondary Outcome Measures