Classification of Breast Masses Based on Visco-elastic Properties Using SAVE Method (SAVE)

March 27, 2026 updated by: Azra Alizad, Mayo Clinic
The purpose of this research is to conduct a clinical study to evaluate the efficacy of a noninvasive and quantitative tool for classification/diagnosis of breast masses. The main objective of this proposal is to test the SAVE (Sub-Hertz Analysis of Visco-Elasticity) method on a patient population of sufficient size to determine the sensitivity and specificity for malignant-benign discrimination of breast masses.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Subject will sit or lie back on an examination bed. The investigators will use an ultrasound scanner to collect sonographic imaging data from the breast. For this purpose the investigators may use a clinical scanner such as Supersonics Aixplorer or similar or a research ultrasound machine such as Verasonics (this machine has been use in other Mayo IRB approved protocols such as IRB 11-001953). The ultrasound probe will be placed on the breast to visualize the mass. The probe will be pressed with a constant force for a period of 10-40 seconds. During this time ultrasound data will be recorded by the ultrasound scanner.

To keep the probe pressed on the breast with a constant force, the user may hold the probe by hand and press it steadily against the breast at constant force. This force is only a few Newtons (approximately half a Kg weight) which should be quite tolerable for a typical patient. Alternatively, the investigators may use an automated "actuator" to hold the probe steady and press it against the breast at a constant force to the same level. The reason for pressing the breast is to determine how the breast tissue gradually deforms; therefore this method to some extent simulates breast palpation.

The time needed to scan a subject for this study is short (a few minutes to set up, and about 10-40 seconds to scan). It will take approximately 20 minutes to complete the study. The scan can be done at the time of clinical breast sonography. The subject may be asked to hold her breath during the scan time if possible.

The investigators call this method "Sub-Hertz Analysis of Visco-Elasticity (SAVE)".

To facilitate subject access and shorten patient participation time, the investigator may station our system in the Breast Imaging area where routine clinical imaging procedures are performed.

The investigators may also use the FDA approved GE LOGIQ E9 (LE9) ultrasound system to quantify and image the stiffness of the breast lesion and compare the results to those obtained by the investigational device.

The investigators may also use the Alpinion clinical ultrasound machine, both FDA approved clinical format ECUBE 12 and non FDA approved ECUBE 12R format to acquire ultrasound images.

Study Type

Observational

Enrollment (Actual)

266

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

Study Population

Females in age range between 18 and up who have a breast lesion that may or may not be suspicious for breast cancer

Description

Inclusion Criteria:

  • Females in age range between 18 and up who have a breast lesion that may or may not be suspicious for breast cancer, and are referred for Radiological investigation.

Exclusion Criteria:

  • No history of mastectomy or implants, or having any condition that does not allow proper use of our imaging devices.
  • Only include patients with masses detectable under ultrasound.

Study Plan

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

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Determine the efficacy of the SAVE method by correlating its results with pathology in a pathology in a population of patients with suspicious breast masses.
Time Frame: Before biopsy or at least 2 weeks post biopsy

Assessed using a two-phase design. The first phase will be the development aspects to determine a candidate threshold for T1 that produces Optimal diagnostic accuracy as quantified by the largest diagnostic odds ratio.

The second phase of the study will be to apply this candidate threshold to the validation sample enrolled as a part of the specific aim to ensure diagnostic utility. For both phases of the analysis, overall diagnostic accuracy will be quantified by the area under the receiver operating characteristics (ROC) curve.
Before biopsy or at least 2 weeks post biopsy
Determine the efficacy of SAVE method in classifying non-specific masses in a group of breast patients on the follow-up list.
Time Frame: Before biopsy or at least 2 weeks post biopsy
The threshold determined in Aim 1 will be applied to the patients in this sample to calculate the diagnostic performance
Before biopsy or at least 2 weeks post biopsy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Azra Alizad, M.D., Mayo Clinic in Rochester

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 19, 2012

Primary Completion (Actual)

June 25, 2024

Study Completion (Actual)

June 25, 2024

Study Registration Dates

First Submitted

April 6, 2021

First Submitted That Met QC Criteria

April 7, 2021

First Posted (Actual)

April 12, 2021

Study Record Updates

Last Update Posted (Actual)

April 1, 2026

Last Update Submitted That Met QC Criteria

March 27, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12-009399
  • R01CA168575 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Breast Cancer

Clinical Trials on FDA approved GE LOGIQ E9 (LE9) ultrasound

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Hong Kong

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe