3D Breast Ultrasound Elastography in Patients Under Neoadjuvant Chemotherapy
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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. |
- 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 |
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| Contact: Alexandra Athanasiou, MD | +33156245823 | alexandra.athanasiou@curie.net |
| France | |
| Curie Cancer Institute | Recruiting |
| Paris, France, 75005 | |
| Contact: Alexandra Athanasiou, MD +33156245823 alexandra.athanasiou@curie.net | |
| 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 May 23, 2013