Ultrasound Tomography Using SoftVue in Diagnosing Women With Breast Cancer

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01698658
Recruitment Status : Recruiting
First Posted : October 3, 2012
Last Update Posted : May 25, 2017
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Zeynep Yilmaz-Saab, Barbara Ann Karmanos Cancer Institute

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
Breast Cancer Other: ultrasound tomography Procedure: magnetic resonance imaging Not Applicable

Detailed Description:


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

II. 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.

III. 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.

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


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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
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 : October 2012
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. Evaluation the SoftVue system with respect to spatial resolution, contrast, sound speed resolution, and attenuation resolution [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: At time of procedure ]
    Will be calculated along with 95% confidence intervals.

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 89 Years   (Adult, Older Adult)
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

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 identifier (NCT number): NCT01698658

United States, Michigan
Barbara Ann Karmanos Cancer Institute Recruiting
Detroit, Michigan, United States, 48201
Contact: Lisa Bey-Knight, RN, BSN    313-576-8607   
Sub-Investigator: Neb Duric, Ph.D.         
Sub-Investigator: Olsi Rama, M.D.         
Sub-Investigator: Lydia Choi, M.D.         
Sub-Investigator: Mark Manning, Ph.D.         
Sub-Investigator: Peter Littrup, M.D.         
Principal Investigator: Zeynep Yilmaz-Saab, M.D.         
Sub-Investigator: Michael Simon, M.D.         
Sub-Investigator: Julie Shultz, M.D.         
Sponsors and Collaborators
Barbara Ann Karmanos Cancer Institute
National Cancer Institute (NCI)
Principal Investigator: Zeynep Yilmaz-Saab Barbara Ann Karmanos Cancer Institute

Responsible Party: Zeynep Yilmaz-Saab, Principal Investigator, Barbara Ann Karmanos Cancer Institute Identifier: NCT01698658     History of Changes
Other Study ID Numbers: 2011-201
NCI-2012-01745 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
First Posted: October 3, 2012    Key Record Dates
Last Update Posted: May 25, 2017
Last Verified: May 2017

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases