Status:
COMPLETED
Computed Tomography Versus Standard 2D Mammography Versus 3D Tomosynthesis
Lead Sponsor:
University of California, Davis
Collaborating Sponsors:
Hologic, Inc.
Conditions:
Breast Cancer
Eligibility:
FEMALE
35+ years
Phase:
NA
Brief Summary
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 scan...
Detailed Description
The primary aim of this study is the comparison of Beta values of several different CT and Tomosynthesis views (Beta of CT Sagittal View, Beta of CT Coronal View, Beta of CT Axial View, Beta of Tomosy...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 4 2016
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT01852032
Start Date
November 1 2010
End Date
March 4 2016
Last Update
April 17 2018
Active Locations (1)
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1
UC Davis Medical Center
Sacramento, California, United States, 95817