Ultrasound Tomography Using SoftVue in Diagnosing Women With Breast Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2016 by Barbara Ann Karmanos Cancer Institute
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Peter Littrup, Barbara Ann Karmanos Cancer Institute
ClinicalTrials.gov Identifier:
First received: September 26, 2012
Last updated: February 11, 2016
Last verified: February 2016
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 Intervention
Breast Cancer
Other: ultrasound tomography
Procedure: magnetic resonance imaging

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Clinical Data Collection for Initial Evaluation of SoftVue: a Novel Ultrasound Breast Scanner

Resource links provided by NLM:

Further study details as provided by Barbara Ann Karmanos Cancer Institute:

Primary Outcome Measures:
  • Evaluation the SoftVue system with respect to spatial resolution, contrast, sound speed resolution, and attenuation resolution [ Time Frame: At time of procedure ] [ Designated as safety issue: No ]
    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:
  • Ability of the system to identify pathological features previously identified by other imaging modalities [ Time Frame: At time of procedure ] [ Designated as safety issue: No ]
    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.

  • Percent agreement between SoftVue (ultrasound tomography classification) and MRI (MR Breast Imaging-Reporting and Data System [BIRADS] classification) [ Time Frame: At time of procedure ] [ Designated as safety issue: No ]
    Will be calculated along with 95% confidence intervals.

  • Sound speed as a percentage measure of dense breast tissue [ Time Frame: At time of procedure ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: October 2012
Estimated Primary Completion Date: April 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.


Ages Eligible for Study:   18 Years to 89 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01698658

United States, Michigan
Barbara Ann Karmanos Cancer Institute Recruiting
Detroit, Michigan, United States, 48201
Contact: Lisa Bey-Knight, RN, BSN    313-576-8607    littrupp@karmanos.org   
Principal Investigator: Peter J. Littrup         
Sub-Investigator: Neb Duric, Ph.D.         
Sub-Investigator: Olsi Rama, M.D.         
Sub-Investigator: Lydia Choi, M.D.         
Sub-Investigator: Mark Manning, Ph.D.         
Sponsors and Collaborators
Barbara Ann Karmanos Cancer Institute
National Cancer Institute (NCI)
Principal Investigator: Peter Littrup Barbara Ann Karmanos Cancer Institute
  More Information

Responsible Party: Peter Littrup, Principal Investigator, Barbara Ann Karmanos Cancer Institute
ClinicalTrials.gov Identifier: NCT01698658     History of Changes
Other Study ID Numbers: 2011-201  NCI-2012-01745 
Study First Received: September 26, 2012
Last Updated: February 11, 2016
Health Authority: United States: Federal Government

ClinicalTrials.gov processed this record on May 30, 2016