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.

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Key information

Conditions

Breast Cancer Arachnodactyly Breast Diseases Breast Neoplasms Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Limb Deformities, Congenital Musculoskeletal Abnormalities Musculoskeletal Diseases Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic, Rochester, Minnesota, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ultrasound

Device

ultrasound scanner to collect sonographic imaging data from the breast

Other names: Supersonics Aixplorer, Verasonics, Alpinion

Primary outcomes

Determine the diagnostic performance of the proposed nonlinear elasticity mapping method by measuring the nonlinear elasticity parameter.

Time frame: Up to 2 weeks post breast biopsy

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.
Diagnostic performance of elasticity heterogeneity with measuring the combined linear and nonlinear elasticity parameters

Time frame: Up to 2 weeks post biopsy

Complement elasticity with additional quantitative information about linear and nonlinear elasticity parameters, that is relevant to the disease mechanism.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

National Cancer Institute (NCI)

Registry information

Important dates

Study start: 2014
Primary completion: 2025
Study completion: 2025
First posted: Apr 28, 2021
Registry last updated: Oct 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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