Comparison of Stationary Breast Tomosynthesis and 2-D Digital Mammography in Patients With Known Breast Lesions

March 19, 2018 updated by: UNC Lineberger Comprehensive Cancer Center

Comparison of Carbon Nanotube X-ray Stationary Digital Breast Tomosynthesis and 2-D Digital Mammography in Patients With Known Breast Lesions.

The goal of the study is to compare the radiologist confidence level in evaluating patients with known breast lesions using a carbon nanotube x-ray based stationary breast tomosynthesis imaging device. The comparison will be made against conventional mammography acquired as a part of a standard clinical workup. One hundred patients who are to have a clinical surgical breast biopsy will be recruited for the study. A reader study will be performed to evaluate the ROC characteristics of the system.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

54

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • The University of North Carolina

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Patients undergoing surgical breast biopsies for lesions detected on mammograms.

Description

Inclusion Criteria:

  • Women at least 18 years old.
  • Scheduled for breast biopsy of at least one breast lesion.
  • Lesion detected on mammogram.
  • Symptomatic by patient self-report, patient self-breast exam or clinical exam.
  • Able to provide informed consent.

Exclusion Criteria:

  • Male. (It is uncommon for men to present for imaging and the overwhelming majority of findings are non-cancerous and do not lead to biopsy; male breast cancer represents <1% of newly diagnosed breast cancer)
  • Less than 18 years of age.
  • Patient unable to give consent.
  • Institutionalized subject (prisoner or nursing home patient).
  • Any woman who is pregnant or has reason to believe she is pregnant or any woman who is lactating

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients
Patients with a breast lesion undergoing surgical biopsy. All patients will undergo stationary Carbon Nanotube x-ray digital breast tomosynthesis imaging in addition to routine conventional digital mammography.
Device: Stationary Carbon Nanotube X-ray Digital Breast Tomosynthesis Scanner
All patients will undergo conventional imaging and imaging with the carbon nanotube based x-ray stationary digital breast tomosynthesis scanner device.
Other Names:
  • Carbon nanotube based x-ray digital breast tomosynthesis (CNT SDBT) Scanner

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Receiver Operative Curve (ROC) Area Under the Curve (AUC) (percentage)
Time Frame: approximately 18 months
Receiver Operative Curve (ROC) Area Under the Curve (AUC) analysis of the stationary breast tomosynthesis (SDBT) system for the the characterization of suspicious breast lesions in comparison to x-ray mammography.
approximately 18 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reader preference - arbitrary units
Time Frame: approximately 18 months
To evaluate radiologists confidence in evaluating specific lesion characteristics in suspicious breast lesions. Readers will be scored from -3 to +3.
approximately 18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UNC Lineberger Comprehensive Cancer Center

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Yueh Z Lee, MD,PhD, University of North Carolina, Chapel Hill
  • Principal Investigator: Cherie M Kuzmiak, DO, University of North Carolina, Chapel Hill

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (ACTUAL)

October 1, 2017

Study Completion (ACTUAL)

January 1, 2018

Study Registration Dates

First Submitted

January 4, 2013

First Submitted That Met QC Criteria

January 18, 2013

First Posted (ESTIMATE)

January 23, 2013

Study Record Updates

Last Update Posted (ACTUAL)

March 20, 2018

Last Update Submitted That Met QC Criteria

March 19, 2018

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LCCC-1232

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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