3D Breast Ultrasound Elastography in Patients Under Neoadjuvant Chemotherapy

Institut National de la Santé Et de la Recherche Médicale, France

Status: Completed

Conditions: Malignant Breast Tumours

Treatments: Device: 3D Ultrasound elastography by means of shear wave propagation into breast tissue

Study type: Interventional

Funder types: Other

Identifiers

NCT01531036

2010-A00663-36 (Registry Identifier)

C10-02

Details and patient eligibility

About

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

Full 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.

Enrollment: 33 patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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33 participants in 1 patient group

shear wave imaging

Experimental group

Description:

Single arm study evaluating breast 3D elastography by means of shear wave propagation into breast tissue.

Treatment:

Device: 3D Ultrasound elastography by means of shear wave propagation into breast tissue