Computed Tomography Versus Standard 2D Mammography Versus 3D Tomosynthesis

Completed · Not applicable

Conditions studied: Breast Cancer

In brief

The purpose of this study is to compare the imaging performance of an investigational breast computed tomography (CT) scanner, built at UC Davis, with that of an FDA-Approved breast tomosynthesis scanner (capable of producing standard 2-D mammography and 3-D tomosynthesis images), built by Hologic, Incorporated, in a group of patients with suspected breast cancer.

Key facts

Study ID

NCT01852032

Run by

University of California, Davis

People needed

23

Starts

2010-11-01

Expected to finish

2016-03-04

Last updated by the study team

2018-04-17

Who can join

Age: 35 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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 5
• 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

You may not qualify if…

• 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

Where it is running

• UC Davis Medical Center — Sacramento, California, United States

Full record on ClinicalTrials.gov

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