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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

February 8, 2012
February 9, 2012
December 2010
July 2013   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01531036 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
3D Breast Ultrasound Elastography in Patients Under Neoadjuvant Chemotherapy
Imagerie 3D d'élasticité du Sein Par échographie Ultrarapide au Cours d'un Traitement Par chimiothérapie néoadjuvante.

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

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.

Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Malignant Breast Tumours
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
Experimental: shear wave imaging
Single arm study evaluating breast 3D elastography by means of shear wave propagation into breast tissue.
Intervention: Device: 3D Ultrasound elastography by means of shear wave propagation into breast tissue
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. Epub 2010 May 26.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
35
September 2013
July 2013   (final data collection date for primary outcome measure)

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
Female
18 Years to 75 Years
No
Contact: Alexandra Athanasiou, MD +33156245823 alexandra.athanasiou@curie.net
France
 
NCT01531036
C10-02, 2010-A00663-36
Yes
Institut National de la Santé Et de la Recherche Médicale, France
Institut National de la Santé Et de la Recherche Médicale, France
Not Provided
Principal Investigator: Alexandra Athanasiou, MD Curie Cancer Institute
Institut National de la Santé Et de la Recherche Médicale, France
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP