Assessment of Response to Neo-adjuvant Chemotherapy for Patients With a Locally Advanced Breast Cancer With 3D Elastography (Shear Wave), (NEO-ELASTO)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02834494|
Recruitment Status : Recruiting
First Posted : July 15, 2016
Last Update Posted : July 13, 2018
|Condition or disease||Intervention/treatment||Phase|
|Breast Neoplasms||Procedure: 3D Shear Wave Elastography (SWE) Biological: Biopsy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||140 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||3D Elastography (Shear Wave) : Assessment of Response to Neo-adjuvant Chemotherapy (NACT) : in Vivo Quantification, for Patients With a Locally Advanced Breast Cancer.|
|Study Start Date :||February 2016|
|Estimated Primary Completion Date :||February 2020|
|Estimated Study Completion Date :||October 2020|
|3D Shear Wave Elastography (SWE)||
Procedure: 3D Shear Wave Elastography (SWE)
Ultrasound imaging with Elastography will be performed at the inclusion (T0), after course 1 and course 2 respectively with anthracyclines, at the end of anthracycline treatment and at the end of taxane treatment.
Optional biopsy of breast tumor under neoadjuvant chemotherapy after the course 2 of anthracycline.
- Assess the accuracy of the sequential measurements by 3D Shear Wave Elastography (SWE) for predicting histological response to neoadjuvant chemotherapy [ Time Frame: up to 32 months ]Measure of the tumor prior to neoadjuvant chemotherapy (T0), at T1 and T2(1stand 2nd courses of anthracycline), at mid-treatment between anthracycline and taxane chemotherapy (Tmi), at the end of chemotherapy before surgery (Tfin).
- Elastic properties before treatment (especially ratio between tumor and glandular breast or fat tissues close to the tumors) [ Time Frame: up to 32 months ]Use technic Supersonic Shear Imaging.
- peritumoral environmental elasticity properties [ Time Frame: up to 32 months ]Use technic Supersonic Shear Imaging (Explorer, Supersonic Imagine).
- Reliable early biomarker of histological response. [ Time Frame: up to 32 months ]Estimate under chemotherapy if early changes in tumor's elasticity can provide a reliable early biomarker of histological response.
- tumor volume changes under treatment by 3D ultrasound [ Time Frame: up to 32 months ]Estimate tumor volume changes under treatment by 3D ultrasound and Compare with measurements obtained by other conventional imaging methods currently used for monitoring patients under neoadjuvant chemotherapy
- Compare changes in tumor elasticity under chemotherapy to variables obtained by other imaging modalities (Breast MRI) performed in clinical routine [ Time Frame: up to 32 months ]
- Compare changes in tumor elasticity under neoadjuvant chemotherapy to changes in diffusion apparent coefficient by using technic Supersonic Shear Imaging (Explorer, Supersonic Imagine). [ Time Frame: up to 32 months ]
- Compare changes in tumor volume to histological response (Gold Standard : surgery after neoadjuvant chemotherapy according to " Residual Cancer Burden " score [ Time Frame: up to 32 months ]
- Compare predictive value (semi-quantitative et quantitative measurements) of tumor elasticity [ Time Frame: up to 32 months ]
- Assess vascular shape and its evolution under treatment by Ultrasensitive Doppler technic "Ultra-Fast Doppler" [ Time Frame: up to 32 months ]
- Compare tumor elasticity to conventional histological parameters [ Time Frame: 6 weeks ]For the additional biopsy (optional) under neoadjuvant chemotherapy at T2, correlation elastography to pathological parameters of peritumoral environment by analyzing conventional histological parameters.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02834494
|Contact: Delphine SEBBAG-SFEZ, MD||33+(1) 56 24 55 email@example.com|
|Institut Curie Paris||Recruiting|
|Paris, France, 75005|
|Principal Investigator: Delphine SEBBAG-SFEZ, MD|