Advanced MR Techniques for Breast Cancer Detection

Breast Cancer Clinical Trial

— RAPIDIRM  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04020523
• Other study ID #: K180603J
• Secondary ID: 2018-A01647-48
• Status: Withdrawn
• Phase: N/A
• Start date: July 2019
• Est. completion date: July 2024

Study information

• Verified date: October 2021
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 2024
• Est. primary completion date: November 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Other:
• MRI sequence
The MR sequences added to the protocol are dedicated sequences for perfusion and diffusion imaging of breast lesion.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	GE Healthcare

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Correlate diffusion MRI parameters with immunochemical markers of tumor angiogenesis on anatomopathological specimen Quantitative diffusion parameter : Apparent Coefficient Diffusion		Day 1 at inclusion
Secondary	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