NCT03487471

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
98

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2018

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

March 16, 2018

Completed
19 days until next milestone

First Posted

Study publicly available on registry

April 4, 2018

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 18, 2023

Completed
Last Updated

May 8, 2024

Status Verified

May 1, 2023

Enrollment Period

3.8 years

First QC Date

March 16, 2018

Last Update Submit

May 7, 2024

Conditions

Breast Diseases

Outcome Measures

Primary Outcomes (2)

  • 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 (1)

  • Examinators learning curve

    baseline until year 1

Study Arms (2)

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

Real-time elastographyDIAGNOSTIC_TEST

Breast ultrasound with real-time elastography

Real-time elastography
Shear wave elastographyDIAGNOSTIC_TEST

Breast ultrasound with shear wave elastography

Shear Wave

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Female patients at least 18 years of age with a known breast lesion
  • Signed informed consent

You may not qualify if:

  • Male
  • Younger than 18 years of age
  • Pregnant or lactating women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St Claraspital

Basel, 4016, Switzerland

Location

MeSH Terms

Conditions

Breast Diseases

Condition Hierarchy (Ancestors)

Skin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Rosanna Zanetti

    St Claraspital Basel

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 16, 2018

First Posted

April 4, 2018

Study Start

March 1, 2018

Primary Completion

December 31, 2021

Study Completion

December 18, 2023

Last Updated

May 8, 2024

Record last verified: 2023-05

Locations

CH(1)