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Completed

NCT Number: NCT03190083

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

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

25 year–85 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Cleveland Clinic, Case Comprehensive Cancer Center

Cleveland, Ohio, 44195, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

2-dimensional mammogram

Device

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.

Digital Breast Tomosynthesis (DBT)

Device

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

Primary outcomes

  1. Number of Participants for Which DBT Altered Surgical Plan

    Time frame: 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

Other outcomes

  1. Variables on 2-Dimensional Mammogram That Might Predict Which Patients Would Benefit From DBT

    Time frame: At completion of 3-Dimensional mammogram (1 day)

  2. The Proportion of Patients Undergoing Additional Work-up Following the DBT

    Time frame: At completion of 3-Dimensional mammogram (1 day)

  3. Number of Patients Undergoing Additional Work-up Following the DBT With Benign Findings

    Time frame: At completion of 3-Dimensional mammogram (1 day)

Sponsors and collaborators

Lead sponsor

Case Comprehensive Cancer Center

Other

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jun 16, 2017
Registry last updated
Jun 27, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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