Nonlinear Elasticity Mapping of Breast Masses

This proposed technique, called "Nonlinear Elasticity Mapping (NEM)", is an innovative approach to estimate (i.e., linear and nonlinear) elasticity to provide complementary and relevant information for identification and characterization of breast masses.

The proposed technique includes imaging the (nonlinear) elasticity parameter in a quantitative manner and measuring two new and relevant parameters. These parameters, together with linear elasticity, are used to differentiate breast masses. The first parameter is the nonlinearity of the elasticity.

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Device: Ultrasound

Detailed Description

Measuring the nonlinearity of elasticity is obtained by recording ultrasound scans of object under different values of externally applied compression, and processing the resulting data. The central element of the proposed method is the solution of an inverse problem by which the linear and nonlinear parameters are estimated and a map of tissue nonlinearity is produced, in which the malignant masses can be identified. In addition to estimating the elasticity, will also evaluate the heterogeneity of the (linear) elasticity parameter distribution within the mass as an indicator of malignancy. In a previously performed pilot study, tested the proposed method on a small group of patients.

The goal of this project is to take the next logical step, which is to test this method in a clinical study on a larger population of patients to obtain statistically meaningful results. Assuming that the proposed method continues to demonstrate high specificity, this technique can have a significant impact on breast cancer diagnosis and management.

• Study Type: Observational
• Enrollment (Actual): 172

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

Female and male patient volunteers, aged 18 years and older, without a history of mastectomy or implants, which are identified to have findings on their clinical breast ultrasound

Description

Inclusion Criteria:

• Without a history of mastectomy or implants, which are identified to have findings on their clinical breast ultrasound.

Exclusion Criteria:

• Previous mastectomy or implants
• Any condition that does not allow proper use of imaging devices.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Determine the diagnostic performance of the proposed nonlinear elasticity mapping method by measuring the nonlinear elasticity parameter.	In order to quantify this diagnostic potential we evaluate the average value of the relative shear modulus and the nonlinear parameter within each mass and correlate the results to the pathology results of breast biopsy.	Up to 2 weeks post breast biopsy
Diagnostic performance of elasticity heterogeneity with measuring the combined linear and nonlinear elasticity parameters	Complement elasticity with additional quantitative information about linear and nonlinear elasticity parameters, that is relevant to the disease mechanism.	Up to 2 weeks post biopsy

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Collaborators: National Cancer Institute (NCI)

Study record dates

Study Major Dates

• Study Start (Actual): July 24, 2014
• Primary Completion (Actual): August 30, 2025
• Study Completion (Actual): August 30, 2025

Study Registration Dates

• First Submitted: April 22, 2021
• First Submitted That Met QC Criteria: April 23, 2021
• First Posted (Actual): April 28, 2021

Study Record Updates

• Last Update Posted (Estimated): October 7, 2025
• Last Update Submitted That Met QC Criteria: October 1, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: Breast; Mass
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Musculoskeletal Abnormalities; Congenital Abnormalities; Limb Deformities, Congenital; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin and Connective Tissue Diseases; Breast Neoplasms; Arachnodactyly; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Imaging; Ultrasonography
• Other Study ID Numbers: 14-004964; R01CA195527 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes