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Withdrawn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
About this trial
This is an interventional diagnostic trial for Breast Cancer focused on measuring MRI, breast, cancer, screening, innovative sequences
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
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
NCT ID
NCT04020523
First Posted
May 24, 2019
Last Updated
October 15, 2021
Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
GE Healthcare
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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