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3D Breast Ultrasound Elastography in Patients Under Neoadjuvant Chemotherapy

Primary Purpose

Malignant Breast Tumours

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
3D Ultrasound elastography by means of shear wave propagation into breast tissue
Sponsored by
Institut National de la Santé Et de la Recherche Médicale, France
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Malignant Breast Tumours

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • Curie Cancer Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

shear wave imaging

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
February 8, 2012
Last Updated
February 24, 2016
Sponsor
Institut National de la Santé Et de la Recherche Médicale, France
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1. Study Identification

Unique Protocol Identification Number
NCT01531036
Brief Title
3D Breast Ultrasound Elastography in Patients Under Neoadjuvant Chemotherapy
Official Title
Imagerie 3D d'élasticité du Sein Par échographie Ultrarapide au Cours d'un Traitement Par chimiothérapie néoadjuvante.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
December 2010 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
November 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut National de la Santé Et de la Recherche Médicale, France

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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
Detailed Description
3D breast ultrasound elastography provides volumetric lesion stiffness details in real time. 3D acquisition is compared to breast MRI in order to evaluate volume measurements calculated in ultrasound. Lesion elasticity is calculated in 3 planes with immediate reconstruction. The purpose of this prospective study is to evaluate the feasibility of this technique and compare the results to those of Breast MRI. For women receiving preoperative chemotherapy, this technique will be evaluated with regard to tumour shrinkage and lesion elasticity modifications under treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malignant Breast Tumours

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
33 (Actual)

8. Arms, Groups, and Interventions

Arm Title
shear wave imaging
Arm Type
Experimental
Arm Description
Single arm study evaluating breast 3D elastography by means of shear wave propagation into breast tissue.
Intervention Type
Device
Intervention Name(s)
3D Ultrasound elastography by means of shear wave propagation into breast tissue
Other Intervention Name(s)
Aixplorer Supersonic Imagine
Intervention Description
Aixplorer Supersonic Imagine Ultrasound System with 3D probe for real-time elastography
Primary Outcome Measure Information:
Title
3D volumetric elasticity measurements
Description
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
Time Frame
10min

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients having already undergone a breast MRI Patients presenting with breast lesions measuring between20-50mm in ultrasound Exclusion Criteria: Multifocal lesions History of breast cancer Breast implants Inflammatory breast disease Pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexandra Athanasiou, MD
Organizational Affiliation
Curie Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Curie Cancer Institute
City
Paris
ZIP/Postal Code
75005
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
20505064
Citation
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.
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3D Breast Ultrasound Elastography in Patients Under Neoadjuvant Chemotherapy

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