Clinical trial NCT04020523: Advanced MR Techniques for Breast Cancer Detection
Official title: Evaluation of Advanced MRI Acquisition Techniques for Perfusion and Diffusion to Detect Breast Cancer
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Breast Cancer
Keywords: MRI
breast
cancer
screening
innovative sequences
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: GE Healthcare
First posted: 2019-07-16
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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

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

Primary outcomes:
measure: Mammary lesions Visualization on ultrafast injected dynamic MRI: Yes/No
timeFrame: Day 1 at inclusion
measure: Mammary lesions Visualization with a diffusion sequence
timeFrame: Day 1 at inclusion
Secondary outcomes:
measure: Quantitative perfusion parameters : Enhancement Integral (EI (%))
timeFrame: Day 1 at inclusion
measure: Quantitative perfusion parameters : Maximum Slope of Increase (MSI (%/sec))
timeFrame: Day 1 at inclusion
measure: Quantitative perfusion parameters : Maximum of enhancement (Rmax (%))
timeFrame: Day 1 at inclusion
measure: Quantitative perfusion parameters : Timing of Maximum of enhancement (RmaxTiming (sec))
timeFrame: Day 1 at inclusion
measure: Quantitative perfusion parameters : Wash-inrate (WIR (%/sec)
timeFrame: Day 1 at inclusion
measure: Correlate diffusion MRI parameters with immunochemical markers of tumor angiogenesis on anatomopathological specimen Quantitative diffusion parameter : Apparent Coefficient Diffusion
timeFrame: Day 1 at inclusion
measure: Evaluate the reduction in the time required to acquire and interpret the new breast MR protocol compared to the standard one
timeFrame: Day 1 at inclusion
Other outcomes:
Locations:
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Isabelle THOMASSIN-NAGGARA, PU-PH
role: PRINCIPAL_INVESTIGATOR
References: