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

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ClinicalTrials.gov Identifier: NCT03487471
Recruitment Status : Recruiting
First Posted : April 4, 2018
Last Update Posted : April 4, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland

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.


Condition or disease Intervention/treatment Phase
Breast Diseases Diagnostic Test: Real-time elastography Diagnostic Test: Shear wave elastography Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 98 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Comparison of Accuracy and Reproducibility of Breast Lesion Characterization Between Real Time Elastography and Shear Wave Elastography
Actual Study Start Date : March 1, 2018
Estimated Primary Completion Date : October 1, 2020
Estimated Study Completion Date : October 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Diseases

Arm Intervention/treatment
Active Comparator: Real-time elastography
98 patients with breast lesion will a receive breast ultrasound (real time elastography)
Diagnostic Test: Real-time elastography
Breast ultrasound with real-time elastography

Active Comparator: Shear Wave
98 patients with breast lesion will a receive breast ultrasound (shear wave elastography)
Diagnostic Test: Shear wave elastography
Breast ultrasound with shear wave elastography




Primary Outcome Measures :
  1. assessment of dignity of breast lesion by use of real-time elastography [ Time Frame: at baseline ]
    variability in breast lesion diagnostics by use of real-time elastography versus shear wave elastography

  2. assessment of dignity of breast lesion by use of shear wave elastography [ Time Frame: at baseline ]
    variability in breast lesion diagnostics by use of real-time elastography versus shear wave elastography


Secondary Outcome Measures :
  1. Examinators learning curve [ Time Frame: baseline until year 1 ]
    Establish learning curves for real-time elastography and shear wave elastography



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03487471


Contacts
Contact: Bettina Wölnerhanssen, MD 0041 61 685 85 85 bettina.woelnerhanssen@usb.ch
Contact: Bettina Wölnerhanssen 0041 61 685 85 85 bettina.woelnerhanssen@usb.ch

Locations
Switzerland
St Claraspital Recruiting
Basel, Switzerland, 4016
Contact: Rosanna Zanetti, MD       Rosanna.zanetti@claraspital.ch   
Contact: Bettina Wölnerhanssen, MD       bettina.woelnerhanssen@claraspital.ch   
Principal Investigator: Rosanna Zanetti, MD         
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Investigators
Principal Investigator: Rosanna Zanetti St Claraspital Basel

Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT03487471     History of Changes
Other Study ID Numbers: Elasto Trial
First Posted: April 4, 2018    Key Record Dates
Last Update Posted: April 4, 2018
Last Verified: April 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Breast Diseases
Skin Diseases