Digital Breast Tomosynthesis Preference Study

This study has been completed.
Sponsor:
Collaborator:
GE Healthcare
Information provided by (Responsible Party):
UNC Lineberger Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00776126
First received: October 17, 2008
Last updated: April 27, 2012
Last verified: April 2012
  Purpose

Mammography remains the current standard in the detection of breast cancer. However, conventional two-view mammography will not detect all cancers. The major limiting factor of conventional mammography is the presence of superimposed breast tissue that can obscure clinically significant lesions. It is this limitation that decreases the sensitivity of mammography and leads to false negative results.

The recent development of digital detectors has allowed imaging technologies such as tomosynthesis to become clinically feasible. The examination, similar to conventional mammography with regard to patient positioning and glandular dose, allows acquisition of a digital data set that can be reconstructed and viewed in multiple sections. The ability of tomosynthesis to unmask overlapping structures has been shown in preliminary studies to increase lesion visibility. Used as either a primary imaging modality, or as an adjunct to screening mammography, tomosynthesis has the potential to provide increased sensitivity and a lower number of false negative examinations.

The purpose of this study is to compare radiologist impression of digital breast tomosynthesis to digital mammography with respect to their ability to see and characterize specific lesion features.


Condition Intervention
Breast Cancer
Device: Digital Breast Tomosynthesis Exam

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Radiologists' Preference Study - Digital Breast Tomosynthesis

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Reader Preference [ Time Frame: upon recruitment/enrollment phase completion ] [ Designated as safety issue: No ]

Enrollment: 51
Study Start Date: October 2008
Study Completion Date: June 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
All enrolled subjects will undergo digital breast tomosynthesis.
Device: Digital Breast Tomosynthesis Exam
Digital Breast Tomosynthesis Exam consisting of single view (MLO) of each breast will be performed.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The subject is a woman ≥18 years of age or older who has no history of symptoms and/or physical signs of breast cancer in either breast (or, if she has had a mastectomy, in the remaining breast);
  • The asymptomatic subject previously (within 3 months) underwent routine screening DM, which showed one or more abnormalities, and was referred for diagnostic mammography within the 30 days before study entry. The images from the screening examination must be available. If the prior screening examination was not conducted at the recruiting site, review of those images by the investigator must confirm that the recommendation for diagnostic mammography is warranted;
  • The subject is able and willing to comply with study procedures, and has signed and dated the informed consent form;
  • The subject is either surgically sterile (has had a documented bilateral oophorectomy and/or documented hysterectomy), or postmenopausal (cessation of menses for more than one year); or, if of childbearing potential, the possibility of pregnancy is remote based on a negative patient history or a negative urine pregnancy test.

Exclusion Criteria:

  • The subject is pregnant or trying to become pregnant;
  • The subject has been previously included in this study;
  • The subject has a history of any symptoms and/or physical signs of breast cancer in either breast (or if she has had a mastectomy, no signs or symptoms of breast cancer in the remaining breast);
  • The subject has breasts too large to be adequately positioned on 19 x 23 centimeter (cm) FFDM digital receptor without anatomical cut off during a DBT examination;
  • The subject has participated in any of the on-going GE studies (GE 190-001, GE 190-002 or GE 190-003), or is participating in, or has participated in (within the prior 30 days), another trial of an investigational product;
  • Has breast implant(s).
  • Has reconstructed breast(s).
  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: NCT00776126

Locations
United States, North Carolina
Breast Imaging Clinic; University of North Carolina Hospitals
Chapel Hill, North Carolina, United States, 27514
Sponsors and Collaborators
UNC Lineberger Comprehensive Cancer Center
GE Healthcare
Investigators
Principal Investigator: Amy S Campbell, MD University of South Carolina
Principal Investigator: Etta D Pisano, MD University of North Carolina, Chapel Hill
  More Information

Additional Information:
Publications:
Responsible Party: UNC Lineberger Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00776126     History of Changes
Other Study ID Numbers: LCCC0803
Study First Received: October 17, 2008
Last Updated: April 27, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by UNC Lineberger Comprehensive Cancer Center:
Breast
3D Digital Mammography
Digital Breast Tomosynthesis

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

ClinicalTrials.gov processed this record on July 29, 2014