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

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

Official Title
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Efficacy of Digital Breast Tomosynthesis (DBT) in Addition to Standard 2- Dimensional Mammography in Evaluating Extent of Disease in Newly Diagnosed Breast Cancer Patients

Conditions
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Breast Cancer

Intervention / Treatment
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* Device: 2-dimensional mammogram
* Device: digital breast tomosynthesis (DBT)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Interventional Model Description: The radiologist reviewing the tomosynthesis images will be separate and blinded from the radiologist who reviewed the initial 2-D mammogram
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 3-dimensional tomosynthesis mammogram<br>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 | Device: 2-dimensional mammogram<br>* This is standard of care for breast cancer diagnosis. The new breast cancer patients will be scheduled for the mammogram after diagnosis at the time of surgical appointment. The radiologist reviewing the tomosynthesis images will be separate and blinded from the radiologist who reviewed the initial 2-D mammogram.<br>Device: digital breast tomosynthesis (DBT)<br>* The radiation dose from this/these procedure(s) will be no more than 0.4mSv for a bi-lateral breast tomosynthesis. The new breast cancer patients will be scheduled for the mammogram after diagnosis at the time of surgical appointment. The radiologist reviewing the tomosynthesis images will be separate and blinded from the radiologist who reviewed the initial 2-D mammogram.<br>* Other names: 3-dimensional mammogram;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants for Which DBT Altered Surgical Plan | 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 | At completion of 3-Dimensional mammogram (1 day) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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3-Dimensional Mammogram, mastectomy, lumpectomy, digital breast tomosynthesis