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

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

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Device: 2-dimensional mammogram; Device: digital breast tomosynthesis (DBT)

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).

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic, Case Comprehensive Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: 3-dimensional tomosynthesis 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

Device: 2-dimensional mammogram; 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.; Device: digital breast tomosynthesis (DBT); 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.; Other Names: 3-dimensional mammogram

What is the study measuring?

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)

Other Outcome Measures

Outcome Measure	Time Frame
Variables on 2-Dimensional Mammogram That Might Predict Which Patients Would Benefit From DBT	At completion of 3-Dimensional mammogram (1 day)
The Proportion of Patients Undergoing Additional Work-up Following the DBT	At completion of 3-Dimensional mammogram (1 day)
Number of Patients Undergoing Additional Work-up Following the DBT With Benign Findings	At completion of 3-Dimensional mammogram (1 day)

Collaborators and Investigators

• Sponsor: Case Comprehensive Cancer Center
• Investigators: Principal Investigator: Nidhi Sharma, MD, Cleveland Clinic, Case Comprehensive Cancer Center

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 1, 2017
• Primary Completion (ACTUAL): June 13, 2018
• Study Completion (ACTUAL): June 13, 2018

Study Registration Dates

• First Submitted: June 14, 2017
• First Submitted That Met QC Criteria: June 15, 2017
• First Posted (ACTUAL): June 16, 2017

Study Record Updates

• Last Update Posted (ACTUAL): June 27, 2022
• Last Update Submitted That Met QC Criteria: June 1, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: mastectomy; lumpectomy; digital breast tomosynthesis; 3-Dimensional Mammogram
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: CASE6117

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes