Computed Tomography Versus Standard 2D Mammography Versus 3D Tomosynthesis
Primary Purpose
Breast Cancer
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Tomosynthesis Breast Scanning
Breast CT Scanning
Sponsored by
About this trial
This is an interventional diagnostic trial for Breast Cancer focused on measuring Breast Cancer
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
Sites / Locations
- UC Davis Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Breast cancer Patients
Arm Description
Tomosynthesis Breast Scanning is done and breast CT Scanning is done.
Outcomes
Primary Outcome Measures
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).
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).
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).
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).
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).
Secondary Outcome Measures
Full Information
NCT ID
NCT01852032
First Posted
October 29, 2012
Last Updated
March 19, 2018
Sponsor
University of California, Davis
Collaborators
Hologic, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT01852032
Brief Title
Computed Tomography Versus Standard 2D Mammography Versus 3D Tomosynthesis
Official Title
Computed Tomography Versus Standard 2D Mammography Versus 3D Tomosynthesis
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
November 2010 (undefined)
Primary Completion Date
March 4, 2016 (Actual)
Study Completion Date
March 4, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, Davis
Collaborators
Hologic, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Breast Cancer
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
23 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Breast cancer Patients
Arm Type
Experimental
Arm Description
Tomosynthesis Breast Scanning is done and breast CT Scanning is done.
Intervention Type
Radiation
Intervention Name(s)
Tomosynthesis Breast Scanning
Intervention Description
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
Intervention Name(s)
Breast CT Scanning
Intervention Description
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.
Primary Outcome Measure Information:
Title
Beta of CT Coronal View
Description
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).
Time Frame
Day 1
Title
Beta of CT Sagittal View
Description
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).
Time Frame
Day 1
Title
Beta of CT Axial View
Description
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).
Time Frame
Day 1
Title
Beta of Tomosynthesis Craniocaudal View
Description
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).
Time Frame
Day 1
Title
Beta of Tomosynthesis Medial Lateral Oblique View
Description
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).
Time Frame
Day 1
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John M Boone, PhD
Organizational Affiliation
University of California, Davis
Official's Role
Principal Investigator
Facility Information:
Facility Name
UC Davis Medical Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
12. IPD Sharing Statement
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Computed Tomography Versus Standard 2D Mammography Versus 3D Tomosynthesis
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