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Computed Tomography Versus Standard 2D Mammography Versus 3D Tomosynthesis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01852032
Recruitment Status : Completed
First Posted : May 13, 2013
Results First Posted : March 16, 2018
Last Update Posted : April 18, 2018
Sponsor:
Collaborator:
Hologic, Inc.
Information provided by (Responsible Party):
University of California, Davis

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Radiation: Tomosynthesis Breast Scanning Radiation: Breast CT Scanning Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Computed Tomography Versus Standard 2D Mammography Versus 3D Tomosynthesis
Study Start Date : November 2010
Actual Primary Completion Date : March 4, 2016
Actual Study Completion Date : March 4, 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Breast cancer Patients
Tomosynthesis Breast Scanning is done and breast CT Scanning is done.
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

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.




Primary Outcome Measures :
  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).




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Ages Eligible for Study:   35 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01852032


Locations
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United States, California
UC Davis Medical Center
Sacramento, California, United States, 95817
Sponsors and Collaborators
University of California, Davis
Hologic, Inc.
Investigators
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Principal Investigator: John M Boone, PhD University of California, Davis
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Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT01852032    
Other Study ID Numbers: 221183
First Posted: May 13, 2013    Key Record Dates
Results First Posted: March 16, 2018
Last Update Posted: April 18, 2018
Last Verified: March 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by University of California, Davis:
Breast Cancer
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases