3D Breast Ultrasound Elastography in Patients Under Neoadjuvant Chemotherapy

• ClinicalTrials.gov Identifier: NCT01531036
• Recruitment Status: Completed
• First Posted: February 10, 2012
• Last Update Posted: February 25, 2016
• Sponsor: Institut National de la Santé Et de la Recherche Médicale, France
• Information provided by (Responsible Party): Institut National de la Santé Et de la Recherche Médicale, France

Tracking Information

• First Submitted Date: February 8, 2012
• First Posted Date: February 10, 2012
• Last Update Posted Date: February 25, 2016
• Study Start Date: December 2010
• Actual Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: February 9, 2012)

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

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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.
• 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.
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Diagnostic
• Condition: Malignant Breast Tumours

Intervention

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

Study Arms

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

• Publications *: 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: February 24, 2016): 33
• Original Estimated Enrollment (submitted: February 9, 2012): 35
• Actual Study Completion Date: November 2012
• Actual Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 18 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: France

Administrative Information

• NCT Number: NCT01531036
• Other Study ID Numbers: C10-02; 2010-A00663-36 ( Registry Identifier: IDRCB )
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Institut National de la Santé Et de la Recherche Médicale, France
• Study Sponsor: Institut National de la Santé Et de la Recherche Médicale, France
• Collaborators: Not Provided

Investigators

• Principal Investigator: Alexandra Athanasiou, MD; Curie Cancer Institute

• PRS Account: Institut National de la Santé Et de la Recherche Médicale, France
• Verification Date: February 2016