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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by UNC Lineberger Comprehensive Cancer Center
Sponsor:
Collaborator:
Information provided by (Responsible Party):
UNC Lineberger Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT01773850
First received: January 4, 2013
Last updated: August 29, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention
Breast Neoplasms
Device: Stationary Carbon Nanotube X-ray Digital Breast Tomosynthesis Scanner

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Comparison of Carbon Nanotube X-ray Stationary Digital Breast Tomosynthesis and 2-D Digital Mammography in Patients With Known Breast Lesions.

Resource links provided by NLM:


Further study details as provided by UNC Lineberger Comprehensive Cancer Center:

Primary Outcome Measures:
  • Receiver Operative Curve (ROC) Area Under the Curve (AUC) (percentage) [ Time Frame: approximately 18 months ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Reader preference - arbitrary units [ Time Frame: approximately 18 months ] [ Designated as safety issue: No ]
    To evaluate radiologists confidence in evaluating specific lesion characteristics in suspicious breast lesions. Readers will be scored from -3 to +3.


Estimated Enrollment: 100
Study Start Date: January 2013
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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 Name: Carbon nanotube based x-ray digital breast tomosynthesis (CNT SDBT) Scanner

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients undergoing surgical breast biopsies for lesions detected on mammograms.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01773850

Contacts
Contact: Yueh Z Lee, MD,PhD 919-537-3730 leey@med.unc.edu

Locations
United States, North Carolina
The University of North Carolina Recruiting
Chapel Hill, North Carolina, United States, 27599
Principal Investigator: Yueh Z Lee, MD,PhD         
Sponsors and Collaborators
UNC Lineberger Comprehensive Cancer Center
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
  More Information

Publications:
Responsible Party: UNC Lineberger Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT01773850     History of Changes
Other Study ID Numbers: LCCC-1232
Study First Received: January 4, 2013
Last Updated: August 29, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by UNC Lineberger Comprehensive Cancer Center:
breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on October 19, 2014