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Computed Tomography Versus Standard 2D Mammography Versus 3D Tomosynthesis

Phase 0
35 Years
Open (Enrolling)
Breast Cancer

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Trial Information

Computed Tomography Versus Standard 2D Mammography Versus 3D Tomosynthesis

The primary aim of this study is the comparison of tumor conspicuity on images taken by both
systems (computed tomography versus standard 2-D mammography versus 3-D tomosynthesis) using
a ten point conspicuity scale as the end-point. Secondary aims will be to compare the number
of lesions detected by the two systems, and to compare the estimated radiation dose of the
two systems.

Inclusion Criteria:

- 35 years of age or older

- While male patients will not be explicitly excluded, it is expected that all patients
in this study will be women

- Diagnostic findings from prior mammography suspicious for, or highly suggestive of,
breast malignancy -BIRADS (Breast Imaging Reporting and Data System) categories 4 and

- Scheduled for ultrasound or stereotactic core biopsy

- Ability to lie still on a table top for up to 10 minutes, longer than the typical
breast CT duration.

- Ability to understand risks, procedures, and benefits involved

Exclusion Criteria:

- Recent breast biopsy

- History of breast augmentation implant

- Pregnant or Positive urine pregnancy test (UPT) or currently breast-feeding

- History of moderate or severe adverse reaction to iodinated contrast injection

- Recent serum creatinine ≥ 1.5 mg/dL

- History of Diabetes Mellitus

- Currently taking Glucophage or Glucovance (Metformin)

- History of chronic asthma

- History of allergy to iodine

- Multiple food and/or drug allergy

- Renal disease

- History of pulmonary disease, phobia of breath holding, or other condition that could
prevent the subject from being able to perform the 16 second breath hold

Type of Study:


Study Design:

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

Outcome Measure:

Tumor conspicuity

Outcome Description:

Comparison of tumor conspicuity using a 10 point conspicuity scale

Outcome Time Frame:

Day 1

Safety Issue:


Principal Investigator

John M Boone, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of California, Davis


United States: Institutional Review Board

Study ID:




Start Date:

November 2010

Completion Date:

November 2013

Related Keywords:

  • Breast Cancer
  • Breast Cancer
  • Breast Neoplasms



UC Davis Medical Center Sacramento, California  95817