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Assessment of Response to Neo-adjuvant Chemotherapy for Patients With a Locally Advanced Breast Cancer With 3D Elastography (Shear Wave), (NEO-ELASTO)

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ClinicalTrials.gov Identifier: NCT02834494
Recruitment Status : Recruiting
First Posted : July 15, 2016
Last Update Posted : December 12, 2018
Sponsor:
Information provided by (Responsible Party):
Institut Curie

Tracking Information
First Submitted Date  ICMJE July 8, 2016
First Posted Date  ICMJE July 15, 2016
Last Update Posted Date December 12, 2018
Study Start Date  ICMJE February 2016
Estimated Primary Completion Date February 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 12, 2016)
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).
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02834494 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 12, 2016)
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE Assessment of Response to Neo-adjuvant Chemotherapy for Patients With a Locally Advanced Breast Cancer With 3D Elastography (Shear Wave),
Official Title  ICMJE 3D Elastography (Shear Wave) : Assessment of Response to Neo-adjuvant Chemotherapy (NACT) : in Vivo Quantification, for Patients With a Locally Advanced Breast Cancer.
Brief Summary Assess the accuracy of the sequential measurements by 3D Shear Wave Elastography (SWE) for predicting histological response to neoadjuvant chemotherapy in patients with locally advanced breast cancer.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Breast Neoplasms
Intervention  ICMJE
  • 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.
  • Biological: Biopsy
    Optional biopsy of breast tumor under neoadjuvant chemotherapy after the course 2 of anthracycline.
Study Arms 3D Shear Wave Elastography (SWE)
Interventions:
  • Procedure: 3D Shear Wave Elastography (SWE)
  • Biological: Biopsy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 12, 2016)
140
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date October 2020
Estimated Primary Completion Date February 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Infiltrating Breast Cancer untreated and/or locally advanced (stages I (T1c), IIa IIb, IIIa, IIIb, IIIc of UICC classification), whatever histological type.
  • Neo-adjuvant chemotherapy decided.(Anthracyclines, taxanes and, for tumors overexpressing human epidermal growth factor receptor 2 (HER2) protein, targeted recombinant humanized monoclonal antibodies)
  • Index tumor whose dimensions are between 10 to 50 mm. Multifocality, and/or multicentricity and/or bilaterality accepted (maximum 2 tumors by breast et tumors well differentiated from each other).
  • Patients aged at least 18 years old at diagnosis
  • Full results conventional breast exams available and no reason to achieve MRI breast exam
  • Patient explanation given and consent information signed

Exclusion Criteria:

  • Pregnant or during lactation
  • Personal history of ipsilateral breast cancer (ipsilateral recurrence or second cancer in the same breast).
  • Patient carrier of cosmetic breast implants
  • Person deprived of liberty or under guardianship
  • Contraindication for receiving neo-adjuvant chemotherapy for any medical reason
  • Inability to submit to medical monitoring of the trial for reasons of geography, social or psychological.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts  ICMJE
Contact: Delphine SEBBAG-SFEZ, MD 33+(1) 56 24 55 89 delphine.sebbagsfez@curie.fr
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02834494
Other Study ID Numbers  ICMJE IC 2015-07
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Institut Curie
Study Sponsor  ICMJE Institut Curie
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Institut Curie
Verification Date December 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP