Clinical trial NCT01852032: Computed Tomography Versus Standard 2D Mammography Versus 3D Tomosynthesis
Official title: Computed Tomography Versus Standard 2D Mammography Versus 3D Tomosynthesis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: Breast Cancer
Lead sponsor: University of California, Davis
Sponsor class: OTHER
Collaborators: name: Hologic, Inc.
First posted: 2013-05-13
Enrollment: 23
Sex: FEMALE
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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).

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
* 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

Primary outcomes:
measure: Beta of CT Coronal View
timeFrame: Day 1
measure: Beta of CT Sagittal View
timeFrame: Day 1
measure: Beta of CT Axial View
timeFrame: Day 1
measure: Beta of Tomosynthesis Craniocaudal View
timeFrame: Day 1
measure: Beta of Tomosynthesis Medial Lateral Oblique View
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: UC Davis Medical Center
state: California
Study officials:
affiliation: University of California, Davis
name: John M Boone, PhD
role: PRINCIPAL_INVESTIGATOR
References: