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Advanced MR Techniques for Breast Cancer Detection (RAPIDIRM)

Primary Purpose

Breast Cancer

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
MRI sequence
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Breast Cancer focused on measuring MRI, breast, cancer, screening, innovative sequences

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Adult patient
  • Patient who has signed a consent form to participate in the study
  • Affiliated patient or beneficiary of a social security scheme
  • Patient with an injected breast MR exam planned as part of her care pathway.

Exclusion Criteria:

  • Patients under guardianship or curatorship
  • Pregnant or breastfeeding patients
  • Patients with contraindications to realization of an MR exam and an injected MR exam

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Patient with an injected breast MR exam

    Arm Description

    Outcomes

    Primary Outcome Measures

    Mammary lesions Visualization on ultrafast injected dynamic MRI: Yes/No
    to evaluate whether ultrafast injected dynamic breast MRI, coupled or not with a diffusion sequence, allows to improve the specificity of standard MRI while maintaining the same sensitivity
    Mammary lesions Visualization with a diffusion sequence
    to evaluate whether ultrafast injected dynamic breast MRI, coupled or not with a diffusion sequence, allows to improve the specificity of standard MRI while maintaining the same sensitivity

    Secondary Outcome Measures

    Quantitative perfusion parameters : Enhancement Integral (EI (%))
    Correlate the parameters of perfusion MR sequence with the markers immunochemicals of tumor angiogenesis on anatomopathological specimen
    Quantitative perfusion parameters : Maximum Slope of Increase (MSI (%/sec))
    Correlate the parameters of perfusion MR sequence with the markers immunochemicals of tumor angiogenesis on anatomopathological specimen
    Quantitative perfusion parameters : Maximum of enhancement (Rmax (%))
    Correlate the parameters of perfusion MR sequence with the markers immunochemicals of tumor angiogenesis on anatomopathological specimen
    Quantitative perfusion parameters : Timing of Maximum of enhancement (RmaxTiming (sec))
    Correlate the parameters of perfusion MR sequence with the markers immunochemicals of tumor angiogenesis on anatomopathological specimen
    Quantitative perfusion parameters : Wash-inrate (WIR (%/sec)
    Correlate the parameters of perfusion MR sequence with the markers immunochemicals of tumor angiogenesis on anatomopathological specimen
    Correlate diffusion MRI parameters with immunochemical markers of tumor angiogenesis on anatomopathological specimen Quantitative diffusion parameter : Apparent Coefficient Diffusion
    Evaluate the reduction in the time required to acquire and interpret the new breast MR protocol compared to the standard one

    Full Information

    First Posted
    May 24, 2019
    Last Updated
    October 15, 2021
    Sponsor
    Assistance Publique - Hôpitaux de Paris
    Collaborators
    GE Healthcare
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04020523
    Brief Title
    Advanced MR Techniques for Breast Cancer Detection
    Acronym
    RAPIDIRM
    Official Title
    Evaluation of Advanced MRI Acquisition Techniques for Perfusion and Diffusion to Detect Breast Cancer
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2021
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Delayed start due to technical problems as well as the covid pandemic. Decision of the investigator
    Study Start Date
    July 2019 (Anticipated)
    Primary Completion Date
    November 2022 (Anticipated)
    Study Completion Date
    July 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Assistance Publique - Hôpitaux de Paris
    Collaborators
    GE Healthcare

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Evaluation of advanced MRI acquisition techniques (perfusion and diffusion) to detect breast cancer. Two MR advanced sequences will be added to a standard breast MRI protocol for evaluation purpose.
    Detailed Description
    This is a prospective monocentric longitudinal study on a consecutive population of patients who require breast MRI as part of their course of care in the radiology department of the Tenon Hospital (3T MRI). The standard protocol for breast MRI routinely performed in Tenon hospital consists of a set of MR acquisitions performed with contrast agent injection. The research consists of adding perfusion and diffusion sequences to the regular MR protocol. The addition of these sequences does not require a new injection of contrast medium. Diagnosis of lesions after the breast MR exam will be performed using standard MR sequences as usual. According to the recommendations of SIFEM, the final diagnosis of the lesions will be made either by histological analysis of a biopsy performed as part of the patient's standard care pathway, or during patient's follow-up if a biopsy is not indicated (up to two years after breast MR exam). The research will focus on evaluating the sensitivity and specificity of perfusion MRI sequence with or without diffusion MRI sequence compared to the sensitivity and specificity of the standard protocol. For the perfusion sequence, the following data will be extracted: qualitative (shape of the contrast curve), semi-quantitative (elevation slope and asymptote of the curve) and quantitative by compartmental modeling (tissue perfusion, blood volume fraction, surface capillary permeability). For the diffusion MRI, the extraction of quantitative data such as CDA, IVIM and Kurtosis will be performed and parametric maps, cellularity maps and an assessment of lesion heterogeneity will be calculated. A correlation will be made with histological, immunohistochemical and molecular results of cancers following biopsy

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Breast Cancer
    Keywords
    MRI, breast, cancer, screening, innovative sequences

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Patient with an injected breast MR exam
    Arm Type
    Experimental
    Intervention Type
    Other
    Intervention Name(s)
    MRI sequence
    Intervention Description
    The MR sequences added to the protocol are dedicated sequences for perfusion and diffusion imaging of breast lesion.
    Primary Outcome Measure Information:
    Title
    Mammary lesions Visualization on ultrafast injected dynamic MRI: Yes/No
    Description
    to evaluate whether ultrafast injected dynamic breast MRI, coupled or not with a diffusion sequence, allows to improve the specificity of standard MRI while maintaining the same sensitivity
    Time Frame
    Day 1 at inclusion
    Title
    Mammary lesions Visualization with a diffusion sequence
    Description
    to evaluate whether ultrafast injected dynamic breast MRI, coupled or not with a diffusion sequence, allows to improve the specificity of standard MRI while maintaining the same sensitivity
    Time Frame
    Day 1 at inclusion
    Secondary Outcome Measure Information:
    Title
    Quantitative perfusion parameters : Enhancement Integral (EI (%))
    Description
    Correlate the parameters of perfusion MR sequence with the markers immunochemicals of tumor angiogenesis on anatomopathological specimen
    Time Frame
    Day 1 at inclusion
    Title
    Quantitative perfusion parameters : Maximum Slope of Increase (MSI (%/sec))
    Description
    Correlate the parameters of perfusion MR sequence with the markers immunochemicals of tumor angiogenesis on anatomopathological specimen
    Time Frame
    Day 1 at inclusion
    Title
    Quantitative perfusion parameters : Maximum of enhancement (Rmax (%))
    Description
    Correlate the parameters of perfusion MR sequence with the markers immunochemicals of tumor angiogenesis on anatomopathological specimen
    Time Frame
    Day 1 at inclusion
    Title
    Quantitative perfusion parameters : Timing of Maximum of enhancement (RmaxTiming (sec))
    Description
    Correlate the parameters of perfusion MR sequence with the markers immunochemicals of tumor angiogenesis on anatomopathological specimen
    Time Frame
    Day 1 at inclusion
    Title
    Quantitative perfusion parameters : Wash-inrate (WIR (%/sec)
    Description
    Correlate the parameters of perfusion MR sequence with the markers immunochemicals of tumor angiogenesis on anatomopathological specimen
    Time Frame
    Day 1 at inclusion
    Title
    Correlate diffusion MRI parameters with immunochemical markers of tumor angiogenesis on anatomopathological specimen Quantitative diffusion parameter : Apparent Coefficient Diffusion
    Time Frame
    Day 1 at inclusion
    Title
    Evaluate the reduction in the time required to acquire and interpret the new breast MR protocol compared to the standard one
    Time Frame
    Day 1 at inclusion

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Adult patient Patient who has signed a consent form to participate in the study Affiliated patient or beneficiary of a social security scheme Patient with an injected breast MR exam planned as part of her care pathway. Exclusion Criteria: Patients under guardianship or curatorship Pregnant or breastfeeding patients Patients with contraindications to realization of an MR exam and an injected MR exam
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Isabelle THOMASSIN-NAGGARA, PU-PH
    Organizational Affiliation
    Assistance Publique - Hôpitaux de Paris
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Advanced MR Techniques for Breast Cancer Detection

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