Comparison of Real-time and Shear Wave Elastography | NCT03487471

Studies
Comparison of Real-time and Shear Wave Elastography

NCT03487471

Sponsor

University Hospital, Basel, Switzerland

Status

Completed

Last Update Posted

May 8, 2024Actual

Enrollment

98Actual

Phase

Not Applicable

Conditions

Breast Diseases

Interventions

Real-time elastography
Shear wave elastography

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1, 2018Actual

Primary Completion Date

Dec 31, 2021Actual

Completion Date

Dec 18, 2023Actual

First Submitted Date

Mar 16, 2018

First Submission Date that Met QC Criteria

Apr 3, 2018

First Posted Date

Apr 4, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 7, 2024

Last Update Posted Date

May 8, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

98Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Real-time elastography	Active Comparator	98 patients with breast lesion will a receive breast ultrasound (real time elastography)	Diagnostic Test: Real-time elastography
Shear Wave	Active Comparator	98 patients with breast lesion will a receive breast ultrasound (shear wave elastography)	Diagnostic Test: Shear wave elastography

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Real-time elastography	Diagnostic Test	Breast ultrasound with real-time elastography	Real-time elastography

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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
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 Outcomes

Measure	Description	Time Frame
Examinators learning curve	Establish learning curves for real-time elastography and shear wave elastography	baseline until year 1

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Rosanna Zanetti	St Claraspital Basel	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
St Claraspital		Basel		4016	Switzerland

Condition Browse Module

MeSH Terms

ID	Term
D001941	Breast Diseases

Ancestor Terms

ID	Term
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases

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