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

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03190083
• Other study ID #: CASE6117
• Status: Completed
• Phase: N/A
• Start date: July 1, 2017
• Est. completion date: June 13, 2018

Study information

• Verified date: June 2022
• Source: Case Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: June 13, 2018
• Est. primary completion date: June 13, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 25 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Cleveland Clinic, Case Comprehensive Cancer Center	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Case Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

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