Advanced MR Techniques for Breast Cancer Detection (RAPIDIRM)

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Breast Cancer
• Intervention / Treatment: Other: MRI sequence

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 Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Day 1 at inclusion
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	Day 1 at inclusion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quantitative perfusion parameters : Enhancement Integral (EI (%))	Correlate the parameters of perfusion MR sequence with the markers immunochemicals of tumor angiogenesis on anatomopathological specimen	Day 1 at inclusion
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	Day 1 at inclusion
Quantitative perfusion parameters : Maximum of enhancement (Rmax (%))	Correlate the parameters of perfusion MR sequence with the markers immunochemicals of tumor angiogenesis on anatomopathological specimen	Day 1 at inclusion
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	Day 1 at inclusion
Quantitative perfusion parameters : Wash-inrate (WIR (%/sec)	Correlate the parameters of perfusion MR sequence with the markers immunochemicals of tumor angiogenesis on anatomopathological specimen	Day 1 at inclusion
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

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborators: GE Healthcare
• Investigators: Principal Investigator: Isabelle THOMASSIN-NAGGARA, PU-PH, Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start (Anticipated): July 1, 2019
• Primary Completion (Anticipated): November 1, 2022
• Study Completion (Anticipated): July 1, 2024

Study Registration Dates

• First Submitted: May 24, 2019
• First Submitted That Met QC Criteria: July 15, 2019
• First Posted (Actual): July 16, 2019

Study Record Updates

• Last Update Posted (Actual): October 20, 2021
• Last Update Submitted That Met QC Criteria: October 15, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: MRI; cancer; breast; screening; innovative sequences
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: K180603J; 2018-A01647-48 (Other Identifier: ANSM)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No