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Radiologists' Preference Study - Digital Breast Tomosynthesis

18 Years
Not Enrolling
Breast Cancer

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Trial Information

Radiologists' Preference Study - Digital Breast Tomosynthesis

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).

Type of Study:


Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Reader Preference

Outcome Time Frame:

upon recruitment/enrollment phase completion

Safety Issue:


Principal Investigator

Amy S Campbell, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of South Carolina


United States: Institutional Review Board

Study ID:




Start Date:

October 2008

Completion Date:

June 2010

Related Keywords:

  • Breast Cancer
  • Breast
  • 3D Digital Mammography
  • Digital Breast Tomosynthesis
  • Breast Neoplasms



Breast Imaging Clinic; University of North Carolina Hospitals Chapel Hill, North Carolina  27514