Clinical trial NCT01698658: Ultrasound Tomography Using SoftVue in Diagnosing Women With Breast Cancer
Official title: Clinical Data Collection for Initial Evaluation of SoftVue: a Novel Ultrasound Breast Scanner
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Lead sponsor: Barbara Ann Karmanos Cancer Institute
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2012-10-03
Enrollment: 657
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Detailed description: PRIMARY OBJECTIVES:

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.

OUTLINE:

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

Eligibility criteria: 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

Primary outcomes:
measure: Evaluation the SoftVue system with respect to spatial resolution, contrast, sound speed resolution, and attenuation resolution
timeFrame: At time of procedure
Secondary outcomes:
measure: Ability of the system to identify pathological features previously identified by other imaging modalities
timeFrame: At time of procedure
measure: Percent agreement between SoftVue (ultrasound tomography classification) and MRI (MR Breast Imaging-Reporting and Data System [BIRADS] classification)
timeFrame: At time of procedure
measure: Sound speed as a percentage measure of dense breast tissue
timeFrame: At time of procedure
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Barbara Ann Karmanos Cancer Institute
state: Michigan
Study officials:
affiliation: Barbara Ann Karmanos Cancer Institute
name: Alit Amit-Yousif, M.D.
role: PRINCIPAL_INVESTIGATOR
References: