Nonlinear Elasticity Mapping of Breast Masses

Recruiting

• Conditions: Breast Cancer

• Registration Number: NCT04863443
• Lead Sponsor: Mayo Clinic

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.

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 Timeline

• Study Start: 2014-07-24
• Study First Submitted: 2021-04-22
• Study First Submitted QC: 2021-04-23
• Study First Posted: 2021-04-28
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-05
• Last Update Posted: 2023-09-06
• Primary Completion: 2024-08-15
• Study Completion: 2024-08-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States