RAPIDIRM: Advanced MR Techniques for Breast Cancer Detection

Sponsor

Assistance Publique - Hôpitaux de Paris (Other)

Overall Status

Withdrawn

CT.gov ID

NCT04020523

Collaborator

GE Healthcare (Industry)

Enrollment

Arm

Anticipated Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer	Other: MRI sequence	N/A

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

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

Evaluation of Advanced MRI Acquisition Techniques for Perfusion and Diffusion to Detect Breast Cancer

Anticipated Study Start Date :

Jul 1, 2019

Anticipated Primary Completion Date :

Nov 1, 2022

Anticipated Study Completion Date :

Jul 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Patient with an injected breast MR exam	Other: MRI sequence The MR sequences added to the protocol are dedicated sequences for perfusion and diffusion imaging of breast lesion.

Arm

Intervention/Treatment

Experimental: Patient with an injected breast MR exam

Other: MRI sequence

The MR sequences added to the protocol are dedicated sequences for perfusion and diffusion imaging of breast lesion.

Outcome Measures

Primary Outcome Measures

Mammary lesions Visualization on ultrafast injected dynamic MRI: Yes/No [Day 1 at inclusion]
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 [Day 1 at inclusion]
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 (%)) [Day 1 at inclusion]
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)) [Day 1 at inclusion]
Correlate the parameters of perfusion MR sequence with the markers immunochemicals of tumor angiogenesis on anatomopathological specimen
Quantitative perfusion parameters : Maximum of enhancement (Rmax (%)) [Day 1 at inclusion]
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)) [Day 1 at inclusion]
Correlate the parameters of perfusion MR sequence with the markers immunochemicals of tumor angiogenesis on anatomopathological specimen
Quantitative perfusion parameters : Wash-inrate (WIR (%/sec) [Day 1 at inclusion]
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 [Day 1 at inclusion]
Evaluate the reduction in the time required to acquire and interpret the new breast MR protocol compared to the standard one [Day 1 at inclusion]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts 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