Clinical trial NCT03190083: Efficacy of Digital Breast Tomosynthesis + Standard 2- Dimensional Mammography in Breast Cancer
Official title: Efficacy of Digital Breast Tomosynthesis (DBT) in Addition to Standard 2- Dimensional Mammography in Evaluating Extent of Disease in Newly Diagnosed Breast Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: mastectomy
lumpectomy
3-Dimensional Mammogram
digital breast tomosynthesis
Lead sponsor: Case Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2017-06-16
Enrollment: 16
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The radiologist reviewing the tomosynthesis images will be separate and blinded from the radiologist who reviewed the initial 2-D mammogram
Primary purpose: DIAGNOSTIC

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).

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

Primary outcomes:
measure: Number of Participants for Which DBT Altered Surgical Plan
timeFrame: At completion of 3-Dimensional mammogram (1 day)
Secondary outcomes:
Other outcomes:
measure: Variables on 2-Dimensional Mammogram That Might Predict Which Patients Would Benefit From DBT
timeFrame: At completion of 3-Dimensional mammogram (1 day)
measure: The Proportion of Patients Undergoing Additional Work-up Following the DBT
timeFrame: At completion of 3-Dimensional mammogram (1 day)
measure: Number of Patients Undergoing Additional Work-up Following the DBT With Benign Findings
timeFrame: At completion of 3-Dimensional mammogram (1 day)
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic, Case Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: Cleveland Clinic, Case Comprehensive Cancer Center
name: Nidhi Sharma, MD
role: PRINCIPAL_INVESTIGATOR
References: