NCT01531036

Brief Summary

Breast Ultrasound Elastography is a complementary technique permitting a better characterization of breast lesions. 3D breast ultrasound elastography is a novel technique permitting a volumetric calculation of lesion stiffness. This could be particularly useful in patients with large breast tumors under pre-operative chemotherapy

Trial Health

87
On Track

Trial Health Score

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

Enrollment
33

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2010

Typical duration 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

December 1, 2010

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

February 8, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 10, 2012

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
Last Updated

August 27, 2025

Status Verified

February 1, 2016

Enrollment Period

1.9 years

First QC Date

February 8, 2012

Last Update Submit

August 26, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 3D volumetric elasticity measurements

    An utrafast shear wave imaging 3-plane acquisition provides several frames of breast lesion elasticity, that are reconstructed by means of a dedicated software thus permitting the direct volumetric elasticity measurements in kPa

    10min

Study Arms (1)

shear wave imaging

EXPERIMENTAL

Single arm study evaluating breast 3D elastography by means of shear wave propagation into breast tissue.

Device: 3D Ultrasound elastography by means of shear wave propagation into breast tissue

Interventions

Aixplorer Supersonic Imagine Ultrasound System with 3D probe for real-time elastography

Also known as: Aixplorer Supersonic Imagine
shear wave imaging

Eligibility Criteria

Age18 Years - 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients having already undergone a breast MRI
  • Patients presenting with breast lesions measuring between20-50mm in ultrasound

You may not qualify if:

  • Multifocal lesions
  • History of breast cancer
  • Breast implants
  • Inflammatory breast disease
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Curie Cancer Institute

Paris, 75005, France

Location

Related Publications (2)

  • Athanasiou A, Latorre-Ossa H, Criton A, Tardivon A, Gennisson JL, Tanter M. Feasibility of Imaging and Treatment Monitoring of Breast Lesions with Three-Dimensional Shear Wave Elastography. Ultraschall Med. 2017 Jan;38(1):51-59. doi: 10.1055/s-0034-1398980. Epub 2015 Mar 5.

    PMID: 25741668BACKGROUND
  • Athanasiou A, Tardivon A, Tanter M, Sigal-Zafrani B, Bercoff J, Deffieux T, Gennisson JL, Fink M, Neuenschwander S. Breast lesions: quantitative elastography with supersonic shear imaging--preliminary results. Radiology. 2010 Jul;256(1):297-303. doi: 10.1148/radiol.10090385. Epub 2010 May 26.

    PMID: 20505064BACKGROUND

Study Officials

  • Alexandra Athanasiou, MD

    Curie Cancer Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 8, 2012

First Posted

February 10, 2012

Study Start

December 1, 2010

Primary Completion

November 1, 2012

Study Completion

November 1, 2012

Last Updated

August 27, 2025

Record last verified: 2016-02

Locations