3D Breast Ultrasound Elastography in Patients Under Neoadjuvant Chemotherapy

Not Applicable

Completed

• Conditions: Malignant Breast Tumours
• Interventions: Device: 3D Ultrasound elastography by means of shear wave propagation into breast tissue

• Registration Number: NCT01531036
• Lead Sponsor: Institut National de la Santé Et de la Recherche Médicale, France

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 Timeline

• Study Start: 2010-12
• Study First Submitted: 2012-02-08
• Study First Submitted QC: 2012-02-09
• Study First Posted: 2012-02-10
• Primary Completion: 2012-11
• Study Completion: 2012-11
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-24
• Last Update Posted: 2016-02-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 33

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
shear wave imaging	3D Ultrasound elastography by means of shear wave propagation into breast tissue	Single arm study evaluating breast 3D elastography by means of shear wave propagation into breast tissue.

Primary Outcome Measures

Name	Time	Method
3D volumetric elasticity measurements	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

Trial Locations

Locations (1)

Curie Cancer Institute; 🇫🇷 Paris, France