Computed Tomography Versus Standard 2D Mammography Versus 3D Tomosynthesis

Breast Cancer Clinical Trial

Official title:

Computed Tomography Versus Standard 2D Mammography Versus 3D Tomosynthesis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01852032
• Other study ID #: 221183
• Status: Completed
• Phase: N/A
• First received: October 29, 2012
• Last updated: March 19, 2018
• Start date: November 2010
• Est. completion date: March 4, 2016

Study information

• Verified date: March 2018
• Source: University of California, Davis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: March 4, 2016
• Est. primary completion date: March 4, 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 35 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer

Intervention

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
• 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.

Locations

Country	Name	City	State
United States	UC Davis Medical Center	Sacramento	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Davis	Hologic, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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