Computed Tomography Versus Standard 2D Mammography Versus 3D Tomosynthesis

University of California (UC) Davis

Status: Completed

Conditions: Breast Cancer

Treatments: Radiation: Breast CT Scanning; Radiation: Tomosynthesis Breast Scanning

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01852032

221183

Details and patient eligibility

About

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.

Full 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).

Enrollment: 23 patients

Sex: Female

Ages: 35+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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23 participants in 1 patient group

Breast cancer Patients

Experimental group

Description:

Tomosynthesis Breast Scanning is done and breast CT Scanning is done.

Treatment:

Radiation: Breast CT Scanning

Radiation: Tomosynthesis Breast Scanning