Computed Tomography Versus Standard 2D Mammography Versus 3D Tomosynthesis
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Breast Cancer
- Sponsor
- University of California, Davis
- Enrollment
- 23
- Locations
- 1
- Primary Endpoint
- Beta of CT Axial View
- Status
- Completed
- Last Updated
- 8 years ago
Overview
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 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.
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 Tomosynthesis Craniocaudal View, Beta of Tomosynthesis Medial Lateral Oblique View). Lower Beta values correspond to better image quality (less noise, increased cancer detection).
Investigators
Eligibility Criteria
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 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 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
Outcomes
Primary Outcomes
Beta of CT Axial View
Time Frame: Day 1
frequency range corresponding to noise power spectrum (NPS) where beta = NPS(f) = af\^-B. beta is calculated as noise corresponding to frequency. The values of the exponent, beta, range from 1.5 to 3.5 Lower Beta values correspond to better image quality (less noise, increased cancer detection).
Beta of CT Coronal View
Time Frame: Day 1
frequency range corresponding to noise power spectrum (NPS) where beta = NPS(f) = af\^-B. beta is calculated as noise corresponding to frequency. The values of the exponent, beta, range from 1.5 to 3.5 Lower Beta values correspond to better image quality (less noise, increased cancer detection).
Beta of Tomosynthesis Craniocaudal View
Time Frame: Day 1
frequency range corresponding to noise power spectrum (NPS) where beta = NPS(f) = af\^-B. beta is calculated as noise corresponding to frequency. The values of the exponent, beta, range from 1.5 to 3.5 Lower Beta values correspond to better image quality (less noise, increased cancer detection).
Beta of CT Sagittal View
Time Frame: Day 1
frequency range corresponding to noise power spectrum (NPS) where beta = NPS(f) = af\^-B. beta is calculated as noise corresponding to frequency. The values of the exponent, beta, range from 1.5 to 3.5 Lower Beta values correspond to better image quality (less noise, increased cancer detection).
Beta of Tomosynthesis Medial Lateral Oblique View
Time Frame: Day 1
frequency range corresponding to noise power spectrum (NPS) where beta = NPS(f) = af\^-B. beta is calculated as noise corresponding to frequency. The values of the exponent, beta, range from 1.5 to 3.5 Lower Beta values correspond to better image quality (less noise, increased cancer detection).