Advanced MR Techniques for Breast Cancer Detection (RAPIDIRM)
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|ClinicalTrials.gov Identifier: NCT04020523|
Recruitment Status : Not yet recruiting
First Posted : July 16, 2019
Last Update Posted : July 16, 2019
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Other: MRI sequence||Not Applicable|
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 (Clinical Trial)|
|Estimated Enrollment :||655 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of Advanced MRI Acquisition Techniques for Perfusion and Diffusion to Detect Breast Cancer|
|Estimated Study Start Date :||July 2019|
|Estimated Primary Completion Date :||November 2022|
|Estimated Study Completion Date :||July 2024|
|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.
- Mammary lesions Visualization on ultrafast injected dynamic MRI: Yes/No [ Time Frame: 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 [ Time Frame: 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
- Quantitative perfusion parameters : Enhancement Integral (EI (%)) [ Time Frame: 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)) [ Time Frame: 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 (%)) [ Time Frame: 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)) [ Time Frame: Day 1 at inclusion ]
- Quantitative perfusion parameters : Wash-inrate (WIR (%/sec) [ Time Frame: Day 1 at inclusion ]
- Correlate diffusion MRI parameters with immunochemical markers of tumor angiogenesis on anatomopathological specimen Quantitative diffusion parameter : Apparent Coefficient Diffusion [ Time Frame: 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 [ Time Frame: Day 1 at inclusion ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04020523
|Contact: Isabelle THOMASSIN-NAGGARA, PU-PH||06 63 06 73 firstname.lastname@example.org|
|Service de Radiologie Hôpital Tenon (APHP)||Not yet recruiting|
|Paris, France, 75020|
|Contact: Isabelle THOMASSIN-NAGGARA 06 63 06 73 21 email@example.com|
|Principal Investigator:||Isabelle THOMASSIN-NAGGARA, PU-PH||Assistance Publique - Hôpitaux de Paris|