Computed Tomography Versus Standard 2D Mammography Versus 3D Tomosynthesis

Not Applicable

Completed

Conditions: Breast Cancer

Interventions: Radiation: Tomosynthesis Breast Scanning
Radiation: Breast CT Scanning

Registration Number: NCT01852032

Lead Sponsor: University of California, Davis

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).

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 23

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
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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Breast cancer Patients	Tomosynthesis Breast Scanning	Tomosynthesis Breast Scanning is done and breast CT Scanning is done.
Breast cancer Patients	Breast CT Scanning	Tomosynthesis Breast Scanning is done and breast CT Scanning is done.

Primary Outcome Measures

Name	Time	Method
Beta of CT Axial View	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	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	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	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	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).