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Ultrasound Tomography Using SoftVue in Diagnosing Women With Breast Cancer

Sponsor
Barbara Ann Karmanos Cancer Institute (Other)
Overall Status
Completed
CT.gov ID
NCT01698658
Collaborator
National Cancer Institute (NCI) (NIH)
657
Enrollment
1
Location
1
Arm
73.5
Duration (Months)
8.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This clinical trial studies ultrasound tomography using SoftVue in diagnosing women with breast cancer. New diagnostic procedures, such as ultrasound tomography using SoftVue, may help find and diagnose breast cancer.

Condition or Disease Intervention/Treatment Phase
  • Other: ultrasound tomography
  • Procedure: magnetic resonance imaging
 N/A

Detailed Description

PRIMARY OBJECTIVES:

  1. Determine the in-vivo imaging potential of SoftVue through 3-dimensional (3-D) breast imaging.

  2. Acquire data for SoftVue evaluation from a cohort of 100 women receiving standard ultrasound (US) evaluation as follow-up to mammographic or palpable abnormalities and construct reflection, sound speed and attenuation images with SoftVue.

  3. Evaluate the ability of SoftVue to detect dominant breast findings (i.e. major normal landmark architecture) or masses previously identified with standard diagnostic evaluation (palpation, mammography, standard US) using standard clock position and radial distance measurements from the nipple.

  4. Conduct tomographic (i.e. slice-by-slice) comparison of SoftVue with magnetic resonance imaging (MRI) findings from a subgroup of 50 patients.

OUTLINE:

Patients undergo ultrasound tomography using SoftVue. Some patients also undergo MRI of the breast.

Study Design

Study Type:
Interventional
Actual Enrollment :
657 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Clinical Data Collection for Initial Evaluation of SoftVue: a Novel Ultrasound Breast Scanner
Study Start Date :
Oct 1, 2012
Actual Primary Completion Date :
Nov 16, 2018
Actual Study Completion Date :
Nov 16, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: Diagnostic (SoftVue ultrasound tomography)

Patients undergo ultrasound tomography using SoftVue. Some patients also undergo MRI of the breast.

Other: ultrasound tomography
Undergo ultrasound tomography using SoftVue

Procedure: magnetic resonance imaging
Undergo MRI of the breast
Other Names:
  • MRI
  • NMR imaging
  • NMRI
  • nuclear magnetic resonance imaging

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Evaluation the SoftVue system with respect to spatial resolution, contrast, sound speed resolution, and attenuation resolution [At time of procedure]

      For each type of resolution, observed values will be averaged over slices for each participant and compared to milestone values. The proportion of individuals whose images meet the milestone criteria will be reported with 95% confidence intervals calculated using Wilson's method.

    Secondary Outcome Measures

    1. Ability of the system to identify pathological features previously identified by other imaging modalities [At time of procedure]

      The sensitivity of the SoftVue system to identify pathologic features will be estimated with 95% confidence intervals using previous imaging studies as the gold standard.

    2. Percent agreement between SoftVue (ultrasound tomography classification) and MRI (MR Breast Imaging-Reporting and Data System [BIRADS] classification) [At time of procedure]

      Will be calculated along with 95% confidence intervals.

    3. Sound speed as a percentage measure of dense breast tissue [At time of procedure]

      Compare measured sound speed values against known values for the range of tissue types imaged (e.g. fatty breasts should have average sound speeds consistent with known speeds for fatty tissue).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 89 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Scheduled for mammogram, breast ultrasound and/or breast MRI

    • Breast size less than 22 cm diameter (ring diameter is 22cm)

    • Able to read or understand and provide informed consent

    • Weight < 350lbs (patient bed max weight)

    • Non-pregnant and non-lactating

    • No open breast or chest wounds

    • No active skin infection

    • No serious medical or psychiatric illnesses that would prevent informed consent

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Barbara Ann Karmanos Cancer Institute Detroit Michigan United States 48201

    Sponsors and Collaborators

    • Barbara Ann Karmanos Cancer Institute
    • National Cancer Institute (NCI)

    Investigators

    • Principal Investigator: Alit Amit-Yousif, M.D., Barbara Ann Karmanos Cancer Institute

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Alit Amit-Yousif, Principal Investigator, Barbara Ann Karmanos Cancer Institute
    ClinicalTrials.gov Identifier:
    NCT01698658
    Other Study ID Numbers:
    • 2011-201
    • NCI-2012-01745
    • P30CA022453
    First Posted:
    Oct 3, 2012
    Last Update Posted:
    May 26, 2022
    Last Verified:
    May 1, 2022
    Additional relevant MeSH terms:
    Breast Neoplasms

    Study Results

    No Results Posted as of May 26, 2022