3D Breast Ultrasound Elastography in Patients Under Neoadjuvant Chemotherapy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2012 by Institut National de la Santé Et de la Recherche Médicale, France.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Institut National de la Santé Et de la Recherche Médicale, France
ClinicalTrials.gov Identifier:
NCT01531036
First received: February 8, 2012
Last updated: February 9, 2012
Last verified: February 2012
  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: 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 ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 35
Study Start Date: December 2010
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: July 2013 (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

Ages Eligible for Study:   18 Years to 75 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01531036

Contacts
Contact: Alexandra Athanasiou, MD +33156245823 alexandra.athanasiou@curie.net

Locations
France
Curie Cancer Institute Recruiting
Paris, France, 75005
Contact: Alexandra Athanasiou, MD    +33156245823    alexandra.athanasiou@curie.net   
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
Study First Received: February 8, 2012
Last Updated: February 9, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

ClinicalTrials.gov processed this record on September 15, 2014