Completed

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

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What is being tested

ultrasound tomography

+ magnetic resonance imaging

OtherProcedure
Who is being recruted

Breast Diseases+3

+ Neoplasms

+ Neoplasms by Site

From 18 to 89 Years
+8 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Diagnostic Study

Interventional
Study Start: October 2012
See protocol details

Summary

Principal SponsorBarbara Ann Karmanos Cancer Institute
Last updated: May 26, 2022
Sourced from a government-validated database.Claim as a partner

Study start date: October 1, 2012

Actual date on which the first participant was enrolled.

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.

NCT01698658
Principal SponsorBarbara Ann Karmanos Cancer Institute
Last updated: May 26, 2022
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

657 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Diagnostic Study

Diagnostic studies focus on improving how we detect or confirm a disease. They test new tools or techniques that could provide faster or more accurate diagnoses.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Female

Biological sex of participants that are eligible to enroll.

From 18 to 89 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Breast DiseasesNeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue DiseasesBreast Neoplasms

Criteria

8 inclusion criteria required to participate
Able to read or understand and provide informed consent
Breast size less than 22 cm diameter (ring diameter is 22cm)
No active skin infection
No open breast or chest wounds
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Barbara Ann Karmanos Cancer Institute

Detroit, United StatesOpen Barbara Ann Karmanos Cancer Institute in Google Maps
CompletedOne Study Center