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

Case Comprehensive Cancer Center (Case CCC)

Status: Completed

Conditions: Breast Cancer

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

Study type: Interventional

Funder types: Other

Identifiers

NCT03190083

CASE6117

Details and patient eligibility

About

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.

Full 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).

Enrollment: 16 patients

Sex: Female

Ages: 25 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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16 participants in 1 patient group

3-dimensional tomosynthesis mammogram

Experimental group

Description:

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

Treatment:

Device: 2-dimensional mammogram

Device: digital breast tomosynthesis (DBT)