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OpenTrials
Completed

NCT Number: NCT01852032

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.

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Key information

Conditions

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

Age range

35 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

UC Davis Medical Center

Sacramento, California, 95817, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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 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.

Primary outcomes

  1. Beta of CT Coronal View

    Time frame: Day 1

    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).

  2. Beta of CT Sagittal View

    Time frame: Day 1

    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).

  3. Beta of CT Axial View

    Time frame: Day 1

    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).

  4. Beta of Tomosynthesis Craniocaudal View

    Time frame: Day 1

    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).

  5. Beta of Tomosynthesis Medial Lateral Oblique View

    Time frame: Day 1

    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).

Sponsors and collaborators

Lead sponsor

University of California, Davis

Other

Collaborators

  • Hologic, Inc.

Registry information

Important dates

Study start
2010
Primary completion
2016
Study completion
2016
First posted
May 13, 2013
Registry last updated
Apr 17, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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