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3D Breast Ultrasound Elastography in Patients Under Neoadjuvant Chemotherapy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01531036
First Posted: February 10, 2012
Last Update Posted: February 25, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Institut National de la Santé Et de la Recherche Médicale, France
  Purpose
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

Condition Intervention
Malignant Breast Tumours Device: 3D Ultrasound elastography by means of shear wave propagation into breast tissue

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Imagerie 3D d'élasticité du Sein Par échographie Ultrarapide au Cours d'un Traitement Par chimiothérapie néoadjuvante.

Resource links provided by NLM:


Further study details as provided by Institut National de la Santé Et de la Recherche Médicale, France:

Primary Outcome Measures:
  • 3D volumetric elasticity measurements [ Time Frame: 10min ]
    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


Enrollment: 33
Study Start Date: December 2010
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: shear wave imaging
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
Aixplorer Supersonic Imagine Ultrasound System with 3D probe for real-time elastography
Other Name: Aixplorer Supersonic Imagine

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.
  Eligibility

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01531036


Locations
France
Curie Cancer Institute
Paris, France, 75005
Sponsors and Collaborators
Institut National de la Santé Et de la Recherche Médicale, France
Investigators
Principal Investigator: Alexandra Athanasiou, MD Curie Cancer Institute
  More Information

Publications:
Responsible Party: Institut National de la Santé Et de la Recherche Médicale, France
ClinicalTrials.gov Identifier: NCT01531036     History of Changes
Other Study ID Numbers: C10-02
2010-A00663-36 ( Registry Identifier: IDRCB )
First Submitted: February 8, 2012
First Posted: February 10, 2012
Last Update Posted: February 25, 2016
Last Verified: February 2016

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases