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Clinical Data Collection for Initial Evaluation of SoftVue: a Novel Ultrasound Breast Scanner

18 Years
89 Years
Open (Enrolling)
Breast Cancer

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Trial Information

Clinical Data Collection for Initial Evaluation of SoftVue: a Novel Ultrasound Breast Scanner


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

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

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

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Evaluation the SoftVue system with respect to spatial resolution, contrast, sound speed resolution, and attenuation resolution

Outcome Description:

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.

Outcome Time Frame:

At time of procedure

Safety Issue:


Principal Investigator

Peter Littrup

Investigator Role:

Principal Investigator

Investigator Affiliation:

Barbara Ann Karmanos Cancer Institute


United States: Federal Government

Study ID:




Start Date:

October 2012

Completion Date:

Related Keywords:

  • Breast Cancer
  • Breast Neoplasms



Barbara Ann Karmanos Cancer Institute Detroit, Michigan  48201