Nonlinear Elasticity Mapping of Breast Masses

NCT04863443 | Completed FDA Device

• 2 other identifiers: 14-004964R01CA195527
• Study Type: observational
• Target: 172
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Breast Cancer

Keywords

Breast; Mass

Outcome Measures

Primary Outcomes (2)

• 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

Interventions

Ultrasound DEVICE

ultrasound scanner to collect sonographic imaging data from the breast

Also known as: Supersonics Aixplorer, Verasonics, Alpinion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Mayo Clinic: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

Mayo Clinic Cancer Center

Rochester, Minnesota, 55905, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Arachnodactyly

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 22, 2021
• First Posted: April 28, 2021
• Study Start: July 24, 2014
• Primary Completion: August 30, 2025
• Study Completion: August 30, 2025
• Last Updated: October 7, 2025

Record last verified: 2025-10

Locations

US (2)