Computed Tomography Versus Standard 2D Mammography Versus 3D Tomosynthesis
Conditions
Breast Cancer
Conditions: Keywords
Breast Cancer
Study Type
Interventional
Study Phase
Phase 0
Study Design
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Intervention
Name: Computed Tomography and Mammography and Tomosynthesis
Type: Radiation
Overall Status
Recruiting
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 tumor conspicuity on images taken by both systems (computed tomography versus standard 2-D mammography versus 3-D tomosynthesis) using a ten point conspicuity scale as the end-point. Secondary aims will be to compare the number of lesions detected by the two systems, and to compare the estimated radiation dose of the two systems.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 35 Years
Gender: Female
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
Location
UC Davis Medical Center
Sacramento, California, United States
Status: Recruiting
Contact: John M Brock, BS - 916-734-3101 - john.brock@ucdmc.ucdavis.edu
Start Date
November 2010
Completion Date
November 2013
Sponsors
University of California, Davis
Source
University of California, Davis
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page