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Comparison of Real-time and Shear Wave Elastography (Elasto)

Primary Purpose

Breast Diseases

Status
Active
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Real-time elastography
Shear wave elastography
Sponsored by
University Hospital, Basel, Switzerland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Breast Diseases

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • St Claraspital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Real-time elastography

Shear Wave

Arm Description

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

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

Outcomes

Primary Outcome Measures

assessment of dignity of breast lesion by use of real-time elastography
variability in breast lesion diagnostics by use of real-time elastography versus shear wave elastography
assessment of dignity of breast lesion by use of shear wave elastography
variability in breast lesion diagnostics by use of real-time elastography versus shear wave elastography

Secondary Outcome Measures

Examinators learning curve
Establish learning curves for real-time elastography and shear wave elastography

Full Information

First Posted
March 16, 2018
Last Updated
May 15, 2023
Sponsor
University Hospital, Basel, Switzerland
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1. Study Identification

Unique Protocol Identification Number
NCT03487471
Brief Title
Comparison of Real-time and Shear Wave Elastography
Acronym
Elasto
Official Title
Comparison of Accuracy and Reproducibility of Breast Lesion Characterization Between Real Time Elastography and Shear Wave Elastography
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 1, 2018 (Actual)
Primary Completion Date
December 31, 2021 (Actual)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Basel, Switzerland

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Diseases

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
98 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Real-time elastography
Arm Type
Active Comparator
Arm Description
98 patients with breast lesion will a receive breast ultrasound (real time elastography)
Arm Title
Shear Wave
Arm Type
Active Comparator
Arm Description
98 patients with breast lesion will a receive breast ultrasound (shear wave elastography)
Intervention Type
Diagnostic Test
Intervention Name(s)
Real-time elastography
Intervention Description
Breast ultrasound with real-time elastography
Intervention Type
Diagnostic Test
Intervention Name(s)
Shear wave elastography
Intervention Description
Breast ultrasound with shear wave elastography
Primary Outcome Measure Information:
Title
assessment of dignity of breast lesion by use of real-time elastography
Description
variability in breast lesion diagnostics by use of real-time elastography versus shear wave elastography
Time Frame
at baseline
Title
assessment of dignity of breast lesion by use of shear wave elastography
Description
variability in breast lesion diagnostics by use of real-time elastography versus shear wave elastography
Time Frame
at baseline
Secondary Outcome Measure Information:
Title
Examinators learning curve
Description
Establish learning curves for real-time elastography and shear wave elastography
Time Frame
baseline until year 1

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rosanna Zanetti
Organizational Affiliation
St Claraspital Basel
Official's Role
Principal Investigator
Facility Information:
Facility Name
St Claraspital
City
Basel
ZIP/Postal Code
4016
Country
Switzerland

12. IPD Sharing Statement

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Comparison of Real-time and Shear Wave Elastography

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