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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
Sponsor:
Collaborator:
GE Healthcare
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Other: MRI sequence Not Applicable

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


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 655 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

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.




Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. Quantitative perfusion parameters : Timing of Maximum of enhancement (RmaxTiming (sec)) [ Time Frame: Day 1 at inclusion ]
    Correlate the parameters of perfusion MR sequence with the markers immunochemicals of tumor angiogenesis on anatomopathological specimen

  5. Quantitative perfusion parameters : Wash-inrate (WIR (%/sec) [ Time Frame: Day 1 at inclusion ]
    Correlate the parameters of perfusion MR sequence with the markers immunochemicals of tumor angiogenesis on anatomopathological specimen

  6. 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 ]
  7. 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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Contacts
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Contact: Isabelle THOMASSIN-NAGGARA, PU-PH 06 63 06 73 21 isabelle.thomassin@aphp.fr

Locations
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France
Service de Radiologie Hôpital Tenon (APHP) Not yet recruiting
Paris, France, 75020
Contact: Isabelle THOMASSIN-NAGGARA    06 63 06 73 21    isabelle.thomassin@aphp.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
GE Healthcare
Investigators
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Principal Investigator: Isabelle THOMASSIN-NAGGARA, PU-PH Assistance Publique - Hôpitaux de Paris

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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT04020523     History of Changes
Other Study ID Numbers: K180603J
2018-A01647-48 ( Other Identifier: ANSM )
First Posted: July 16, 2019    Key Record Dates
Last Update Posted: July 16, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Assistance Publique - Hôpitaux de Paris:
MRI
breast
cancer
screening
innovative sequences
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases