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Solving the preoperative breast MRI conundrum: design and protocol of the MIPA study

Abstract

Despite its high diagnostic performance, the use of breast MRI in the preoperative setting is controversial. It has the potential for personalized surgical management in breast cancer patients, but two of three randomized controlled trials did not show results in favor of its introduction for assessing the disease extent before surgery. Meta-analyses showed a higher mastectomy rate in women undergoing preoperative MRI compared to those who do not. Nevertheless, preoperative breast MRI is increasingly used and a survey from the American Society of Breast Surgeons showed that 41% of respondents ask for it in daily practice. In this context, a large-scale observational multicenter international prospective analysis (MIPA study) was proposed under the guidance of the European Network for the Assessment of Imaging in Medicine (EuroAIM). The aims were (1) to prospectively and systematically collect data on consecutive women with a newly diagnosed breast cancer, not candidates for neoadjuvant therapy, who are offered or not offered breast MRI before surgery according to local practice; (2) to compare these two groups in terms of surgical and clinical endpoints, adjusting for covariates. The underlying hypotheses are that MRI does not cause additional mastectomies compared to conventional imaging, while reducing the reoperation rate in all or in subgroups of patients. Ninety-six centers applied to a web-based call; 36 were initially selected based on volume and quality standards; 27 were active for enrollment. On November 2018, the target of 7000 enrolled patients was reached. The MIPA study is presently at the analytic phase.

Key Points

Breast MRI has a high diagnostic performance but its utility in the preoperative setting is controversial.

• A large-scale observational multicenter prospective study was launched to compare women receiving with those not receiving preoperative MRI.

• Twenty-seven centers enrolled more than 7000 patients. The study is presently at the analytic phase.

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Fig. 1

Abbreviations

BCS:

Breast-conserving surgery

EuroAIM:

European Network for the Assessment of Imaging in Medicine

EUSOBI:

European Society of Breast Imaging

MRI:

Magnetic resonance imaging

OR:

Odds ratio

RCT:

Randomized controlled trial

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Acknowledgments

The study was promoted by the European Network for the Assessment of Imaging in Medicine (EuroAIM), initiative of the European Institute for Biomedical Imaging Research (EIBIR) and endorsed by the European Society of Breast Imaging. The authors thank Bayer Healthcare that provided an unconditional research grant, in particular Dr. Stephanie Schermuck-Joschko (who passed away for a car accident after the study started) and Dr. Jan Endrikat. The authors also thank Monika Hierath, Eva Haas, Katharina Krischak, and Peter Gordebeke from the EIBIR staff which managed all the administrative work of this study.

The following persons collaborated at individual centers: Lucia Camera, MD, Department of Radiology, Azienda Ospedaliera Universitaria Integrata, Verona, Italy; Sara Mirandola, MD, Department of Surgery, Azienda Ospedaliera Universitaria Integrata, Verona, Italy; Marta Maria Panzeri, MD, Department of Breast Radiology, IRCCS Ospedale San Raffaele, Milan, Italy; Maria A. Rodi Carvalho Barros Bernardes, MD and Vera L. Nunes Aguillar, MD, PhD, Department of Radiology, Hospital Sirio Libanes, Sao Paulo, Brazil; Katja Siegmann-Luz, MD and Benjamin Wiesinger, MD, Department of Diagnostic and Interventional Radiology, University Hospital of Tuebingen, Germany; James M. Anderson, Max Hobbs, and Wanda Gunawan, Royal Perth Hospital, Perth, Australia.

Funding

This study has received funding by Bayer Healthcare.

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Corresponding author

Correspondence to Francesco Sardanelli.

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Guarantor

The scientific guarantor of this publication is Professor Francesco Sardanelli (Università degli Studi di Milano).

Conflict of interest

The authors of this manuscript declare the following relationships with companies:

Thomas Helbich receives research funding from Siemens, Guerbet, Bracco, Hologic and Nocomed.

Francesco Sardanelli received research grants from and is a member of the speakers’ bureau of GE Healthcare, Bayer, and Bracco; he is also a member of the Bracco Advisory Group.

Fiona J Gilbert received research grants from GE Healthcare, GSK, and Hologic and had research collaborations with Volpara and Bayer. She is an NIHR senior investigator and receives funding from the Cambridge BRC.

Marc Lobbes received research grant and is a member of the speakers’ bureau of GE Healthcare.

Nehmat Houssami receives research funding via a National Breast Cancer Foundation (NBCF Australia) Breast Cancer Research Leadership Fellowship.

Statistics and biometry

One of the authors has significant statistical expertise.

Informed consent

Written informed consent was obtained from all subjects (patients) in this study.

Ethical approval

Institutional Review Board approval was obtained.

Methodology

• prospective

• observational

• multicenter study

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Sardanelli, F., Trimboli, R.M., Houssami, N. et al. Solving the preoperative breast MRI conundrum: design and protocol of the MIPA study. Eur Radiol 30, 5427–5436 (2020). https://doi.org/10.1007/s00330-020-06824-7

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Keywords

  • Breast neoplasms
  • Breast-conserving surgery
  • Magnetic resonance imaging
  • Mastectomy
  • Prospective studies