Comparison of Real-time and Shear Wave Elastography

NCT ID: NCT03487471

Last Updated: 2024-05-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 98 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-01
• Study Completion Date: 2023-12-18

Brief Summary

Tissue elasticity is being increasingly used as diagnostic parameter, since at the macroscopic level benign breast lesions tend to be stiffer than normal breast tissue but softer than breast cancers. Ultrasound elastography allows to probe the elasticity of breast lesions in clinics. Real time elastography (RTE) and shear wave elastography (SWE) are the two most widely used elastography modalities.

Assessment of breast lesions by either RTE or SWE improve the diagnostic performance of standard B-mode ultrasound (US) and have the potential to assist the decision about whether to perform a breast biopsy or not.

Detailed Description

Tissue elasticity is being increasingly used as diagnostic parameter, since at the macroscopic level benign breast lesions tend to be stiffer than normal breast tissue but softer than breast cancers. Ultrasound elastography allows to probe the elasticity of breast lesions in clinics. Real time elastography (RTE) and shear wave elastography (SWE) are the two most widely used elastography modalities.

Assessment of breast lesions by either RTE or SWE improve the diagnostic performance of standard B-mode ultrasound (US) and have the potential to assist the decision about whether to perform a breast biopsy or not. However, employing RTE and SWE using the same equipment to directly compare elasticity measurements of a breast lesion has not been done. Investigators propose to prospectively investigate inter-observer agreement of each modality.

The study will investigate and compare the accuracy and reproducibility of SWE and RTE in the characterization of breast lesions. Furthermore, we plan to establish learning curves for RTE and SWE.

In this project, investigators will compare RTE and SWE concerning their potential to discriminate benign breast lesions from breast cancer. Investigators aim is to identify which modality will allow clinicians the best possible patient care.

Conditions

Breast Diseases

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Real-time elastography

98 patients with breast lesion will a receive breast ultrasound (real time elastography)

Group Type: ACTIVE_COMPARATOR

Real-time elastography

Intervention Type: DIAGNOSTIC_TEST

Breast ultrasound with real-time elastography

Shear Wave

98 patients with breast lesion will a receive breast ultrasound (shear wave elastography)

Group Type: ACTIVE_COMPARATOR

Shear wave elastography

Intervention Type: DIAGNOSTIC_TEST

Breast ultrasound with shear wave elastography

Interventions

Real-time elastography

Breast ultrasound with real-time elastography

Intervention Type: DIAGNOSTIC_TEST

Shear wave elastography

Breast ultrasound with shear wave elastography

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• Female patients at least 18 years of age with a known breast lesion
• Signed informed consent

Exclusion Criteria

• Male
• Younger than 18 years of age
• Pregnant or lactating women

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Basel, Switzerland

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rosanna Zanetti

Role: PRINCIPAL_INVESTIGATOR

St Claraspital Basel

Locations

St Claraspital

Basel, , Switzerland

Countries

Switzerland

Other Identifiers

Elasto Trial

Identifier Type: -

Identifier Source: org_study_id