Computed Tomography Versus Standard 2D Mammography Versus 3D Tomosynthesis

NCT01852032 | Completed Results FDA Device

• 1 other identifier: 221183
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

Breast Cancer

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (1)

Breast cancer Patients

EXPERIMENTAL

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

Radiation: Tomosynthesis Breast Scanning; Radiation: Breast CT Scanning

Interventions

Tomosynthesis Breast Scanning 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 cancer Patients

Breast CT Scanning 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.

Breast cancer Patients

Eligibility Criteria

• Age: 35 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Davis: lead
• Hologic, Inc.: collaborator

Study Sites (1)

UC Davis Medical Center

Sacramento, California, 95817, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: John Brock Staff Research Associate
• Organization: UC Davis

jmbrock@ucdavis.edu

916-734-3101

Study Officials

• John M Boone, PhD

  University of California, Davis

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2012
• First Posted: May 13, 2013
• Study Start: November 1, 2010
• Primary Completion: March 4, 2016
• Study Completion: March 4, 2016
• Last Updated: April 17, 2018
• Results First Posted: March 16, 2018

Record last verified: 2018-03

Locations

US (1)