Computed Tomography Versus Standard 2D Mammography Versus 3D Tomosynthesis

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Radiation: Tomosynthesis Breast Scanning; Radiation: Breast CT Scanning

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).

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Sacramento, California, United States, 95817
      • UC Davis Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: Breast cancer Patients; Tomosynthesis Breast Scanning is done and breast CT Scanning is done.

Radiation: Tomosynthesis Breast Scanning; The breast is positioned and compressed the same way it is in a conventional mammogram using a compression paddle device. The subject will be instructed to hold their breath and not move during the 7- second 3-D tomosynthesis acquisition. The affected breast is positioned with MLO compression. The radiation dose levels for each scan are equivalent to mammography; Radiation: Breast CT Scanning; CT scanning will be performed before and after I.V. iodine contrast injection. The subject will lie prone on a large table (which is covered by a foam pad), and she will place the breast to be scanned in a small hole in that tabletop. The hole is surrounded by a soft neoprene "hammock," which will allow the subject's entire upper torso to slump into the scan plane of the device. After positioning of the affected breast by a female mammography technologist, the subject will be instructed to hold their breath for 16 seconds and the pre-contrast scan will commence. There will be no breast compression. Other than the sound of the relatively noisy x-ray system in the room, the subject will not feel or sense any aspect of this scan.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Beta of CT Coronal View	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).	Day 1
Beta of CT Sagittal View	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).	Day 1
Beta of CT Axial View	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).	Day 1
Beta of Tomosynthesis Craniocaudal View	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).	Day 1
Beta of Tomosynthesis Medial Lateral Oblique View	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).	Day 1

Collaborators and Investigators

• Sponsor: University of California, Davis
• Collaborators: Hologic, Inc.
• Investigators: Principal Investigator: John M Boone, PhD, University of California, Davis

Study record dates

Study Major Dates

• Study Start: November 1, 2010
• Primary Completion (ACTUAL): March 4, 2016
• Study Completion (ACTUAL): March 4, 2016

Study Registration Dates

• First Submitted: October 29, 2012
• First Submitted That Met QC Criteria: May 8, 2013
• First Posted (ESTIMATE): May 13, 2013

Study Record Updates

• Last Update Posted (ACTUAL): April 17, 2018
• Last Update Submitted That Met QC Criteria: March 19, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Keywords: Breast Cancer
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: 221183

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes