Breast DiseasesElastoNCT03487471
Comparison of Real-time and Shear Wave Elastography
A study testing Real-time elastography and Shear wave elastography in people with Breast Diseases, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Diseases
- What is being tested?
- Real-time elastography and Shear wave elastography
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Mar 2018to 18 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female patients at least 18 years of age with a known breast lesion
- Signed informed consent
Who cannot join
- Male
- Younger than 18 years of age
- Pregnant or lactating women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Accuracy and Reproducibility of Breast Lesion Characterization Between Real Time Elastography and Shear Wave Elastography
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.
Read the 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
- Being tested
- Real-time elastography, Shear wave elastography
- Medical subject headings
- Breast Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Real-time elastographyDiagnostic test
Breast ultrasound with real-time elastography
Shear wave elastographyDiagnostic test
Breast ultrasound with shear wave elastography
| Study group | Role | What they receive |
|---|---|---|
| Real-time elastography | Active comparator | 98 patients with breast lesion will a receive breast ultrasound (real time elastography) Receives: Diagnostic Test: Real-time elastography |
| Shear Wave | Active comparator | 98 patients with breast lesion will a receive breast ultrasound (shear wave elastography) Receives: Diagnostic Test: Shear wave elastography |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: at baseline
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
Measured: at baseline
Secondary outcomes (1)
Examinators learning curve
Establish learning curves for real-time elastography and shear wave elastography
Measured: baseline until year 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2018
- Study start1 Mar 2018
- Primary completion31 Dec 2021
- Study completion18 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rosanna Zanetti, Principal investigator, St Claraspital Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03487471
- Sponsor's protocol ID
- Elasto Trial
- Acronym
- Elasto
- Status last verified
- May 2023
- First submitted
- 16 Mar 2018
- Last updated
- 8 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Accuracy and Reproducibility of Breast Lesion Characterization Between Real Time Elastography and Shear Wave Elastography
- ClinicalTrials.gov ID
- NCT03487471
- Acronym / sponsor ID
- Elasto / Elasto Trial
- Conditions
- Breast Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 18 Dec 2023 (actual)
- First posted
- 4 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Real-time elastography | Active comparator | Diagnostic Test: Real-time elastography98 patients with breast lesion will a receive breast ultrasound (real time elastography) |
| Shear Wave | Active comparator | Diagnostic Test: Shear wave elastography98 patients with breast lesion will a receive breast ultrasound (shear wave elastography) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Female patients at least 18 years of age with a known breast lesion
- Signed informed consent
Key exclusion criteria (3 listed)
- Male
- Younger than 18 years of age
- Pregnant or lactating women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Real-time elastographyBreast ultrasound with real-time elastography | Diagnostic test | Real-time elastography |
| Shear wave elastographyBreast ultrasound with shear wave elastography | Diagnostic test | Shear Wave |
Primary outcome
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
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
1 secondary outcome
Examinators learning curve
Time frame: baseline until year 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rosanna Zanetti principal investigator
St Claraspital Basel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Real-time elastography and Shear wave elastography in people with Breast Diseases, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
assessment of dignity of breast lesion by use of real-time elastography (time frame: at baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2024; AzTrials last refreshed its copy on 30 Oct 2026.