Computed Tomography Versus Standard 2D Mammography Versus 3D Tomosynthesis

NCT ID: NCT01852032

Last Updated: 2018-04-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-11-30
• Study Completion Date: 2016-03-04

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).

Conditions

Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Breast cancer Patients

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

Group Type: EXPERIMENTAL

Tomosynthesis Breast Scanning

Intervention Type: RADIATION

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

Breast CT Scanning

Intervention Type: RADIATION

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.

Interventions

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

Intervention Type: 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.

Intervention Type: RADIATION

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

• Minimum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Hologic, Inc.

INDUSTRY

Sponsor Role: collaborator

University of California, Davis

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

John M Boone, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, Davis

Locations

UC Davis Medical Center

Sacramento, California, United States

Countries

United States

Other Identifiers

221183

Identifier Type: -

Identifier Source: org_study_id