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Digital Breast Tomosynthesis Preference Study (NRR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00776126
Recruitment Status : Completed
First Posted : October 20, 2008
Last Update Posted : March 6, 2017
GE Healthcare
Information provided by (Responsible Party):
UNC Lineberger Comprehensive Cancer Center

Brief Summary:

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 or disease Intervention/treatment
Breast Cancer Device: Digital Breast Tomosynthesis Exam

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Study Type : Observational
Actual Enrollment : 51 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Radiologists' Preference Study - Digital Breast Tomosynthesis
Study Start Date : October 2008
Actual Primary Completion Date : April 2010
Actual Study Completion Date : June 2010

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
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.

Primary Outcome Measures :
  1. Reader Preference [ Time Frame: upon recruitment/enrollment phase completion ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult women who have undergone previous screening with CR digital mammography and were scheduled for diagnostic workup with full-field digital mammography (FFDM).

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00776126

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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
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Principal Investigator: Amy S Campbell, MD University of South Carolina
Principal Investigator: Etta D Pisano, MD University of North Carolina, Chapel Hill
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Responsible Party: UNC Lineberger Comprehensive Cancer Center Identifier: NCT00776126    
Other Study ID Numbers: LCCC 0803
First Posted: October 20, 2008    Key Record Dates
Last Update Posted: March 6, 2017
Last Verified: March 2017
Keywords provided by UNC Lineberger Comprehensive Cancer Center:
3D Digital Mammography
Digital Breast Tomosynthesis