Advanced MR Techniques for Breast Cancer Detection

NCT ID: NCT04020523

Last Updated: 2021-10-20

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-31
• Study Completion Date: 2024-07-31

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

Conditions

Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Patient with an injected breast MR exam

Group Type: EXPERIMENTAL

MRI sequence

Intervention Type: OTHER

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

Interventions

MRI sequence

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

GE Healthcare

INDUSTRY

Sponsor Role: collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Isabelle THOMASSIN-NAGGARA, PU-PH

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Other Identifiers

2018-A01647-48

Identifier Type: OTHER

Identifier Source: secondary_id

K180603J

Identifier Type: -

Identifier Source: org_study_id