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

NCT03190083 | Completed Results DMC FDA Device

• 1 other identifier: CASE6117
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

mastectomy; lumpectomy; 3-Dimensional Mammogram; digital breast tomosynthesis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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)

Study Arms (1)

3-dimensional tomosynthesis mammogram

EXPERIMENTAL

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; Device: digital breast tomosynthesis (DBT)

Interventions

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.

3-dimensional tomosynthesis 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.

Also known as: 3-dimensional mammogram

3-dimensional tomosynthesis mammogram

Eligibility Criteria

• Age: 25 Years - 85 Years
• Gender Eligibility Details: Patient with a diagnosis of breast cancer and identifying as female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• High risk benign lesions as the primary pathology diagnosis

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead

Study Sites (1)

Cleveland Clinic, Case Comprehensive Cancer Center

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Mammography

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Radiography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Results Point of Contact

• Title: Dr. Nidhi Sharma
• Organization: Cleveland Clinic, Case Comprehensive Cancer Center

sharman2@ccf.org

+1 216-444-9014

Study Officials

• Nidhi Sharma, MD

  Cleveland Clinic, Case Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The radiologist reviewing the tomosynthesis images will be separate and blinded from the radiologist who reviewed the initial 2-D mammogram

Study Record Dates

• First Submitted: June 14, 2017
• First Posted: June 16, 2017
• Study Start: July 1, 2017
• Primary Completion: June 13, 2018
• Study Completion: June 13, 2018
• Last Updated: June 27, 2022
• Results First Posted: April 10, 2020

Record last verified: 2022-06

Locations

US (1)