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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03487471
Other study ID # Elasto Trial
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 1, 2018
Est. completion date December 18, 2023

Study information

Verified date May 2023
Source University Hospital, Basel, Switzerland
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 98
Est. completion date December 18, 2023
Est. primary completion date December 31, 2021
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Real-time elastography
Breast ultrasound with real-time elastography
Shear wave elastography
Breast ultrasound with shear wave elastography

Locations

Country Name City State
Switzerland St Claraspital Basel

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 at baseline
Primary 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 at baseline
Secondary Examinators learning curve Establish learning curves for real-time elastography and shear wave elastography baseline until year 1
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