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

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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.

Author information

Authors and Affiliations

  1. Department of Biomedical Sciences for Health, Università degli Studi di Milano, Via Morandi 30, 20097, San Donato Milanese, Italy

    Francesco Sardanelli & Rubina M. Trimboli

  2. Unit of Radiology, IRCCS Policlinico San Donato, Via Morandi 30, 20097, San Donato Milanese, Italy

    Francesco Sardanelli & Giovanni Di Leo

  3. Sydney School of Public Health, Faculty of Medicine and Health, The University of Sydney, Camperdown, NSW, Australia

    Nehmat Houssami

  4. Department of Radiology, Cambridge Biomedical Campus, University of Cambridge, Cambridge, UK

    Fiona J. Gilbert & Sarah Hilborne

  5. Department of Biomedical Imaging and Image-guided Therapy, Division of Molecular and Gender Imaging, Medical University of Vienna, Vienna, Austria

    Thomas H. Helbich & Paola Clauser

  6. Department of Radiology, Hospital Universitario Reina Sofía, Córdoba, Spain

    Marina Alvarez Benito

  7. Department of Radiology, Gustave-Roussy Institute, Villejuif, France

    Corinne Balleyguier

  8. Institute of Radiology, Department of Medicine, University of Udine, University Hospital S. Maria della Misericordia, Udine, Italy

    Massimo Bazzocchi, Rossano Girometti & Chiara Zuiani

  9. Department of Pathology, Radboud University Medical Center, Nijmegen, The Netherlands

    Peter Bult

  10. Unit of Breast Radiology, IRCCS Ospedale Policlinico San Martino, Genoa, Italy

    Massimo Calabrese

  11. Department of Radiology, University Hospital of La Ribera, Alzira, Spain

    Julia Camps Herrero

  12. Jefa Corporativa del Área de la Mama, Ribera Salud Grupo, Valencia, Spain

    Julia Camps Herrero

  13. Unit of Breast Imaging, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy

    Francesco Cartia, Catherine Depretto & Gianfranco P. Scaperrotta

  14. Breast Imaging Division, European Institute of Oncology, Milan, Italy

    Enrico Cassano

  15. Department of Breast Surgery, Hospital Sírio Libanês, Sao Paulo, Brazil

    Danubia A. de Andrade

  16. Department of Radiology, Hospital Sírio Libanês, Sao Paulo, Brazil

    Marcos F. de Lima Docema

  17. Department of Radiology, MHEK Teaching Hospital University Semmelweis, Budapest, Hungary

    Gabor Forrai

  18. Department of Radiology, Duna Medical Center, Budapest, Hungary

    Gabor Forrai

  19. Breast Center of Northwest Arkansas, Fayetteville, AR, USA

    Steven E. Harms

  20. Department of Radiology Di.Bi.MED, University of Palermo, Policlinico P. Giaccone, Palermo, Italy

    Raffaele Ienzi

  21. Department of Radiology and Nuclear Medicine, Maastricht University Medical Center, Maastricht, The Netherlands

    Marc B. I. Lobbes

  22. Department of Radiology, Zuyderland Medical Center, Sittard-Geleen, The Netherlands

    Marc B. I. Lobbes

  23. Department of Breast Radiology, IRCCS Ospedale San Raffaele, Milan, Italy

    Claudio Losio

  24. Department of Radiology and Nuclear Medicine, Radboud University Nijmegen Medical Center, Nijmegen, The Netherlands

    Ritse M. Mann

  25. Department of Radiology, The Netherlands Cancer Institute, Amsterdam, The Netherlands

    Ritse M. Mann

  26. Department of Radiology, University Hospital of Verona, Verona, Italy

    Stefania Montemezzi

  27. Department of Radiology and Nuclear Medicine, Erasmus University Medical Center, Rotterdam, The Netherlands

    Inge-Marie Obdeijn

  28. Unit of Radiology, Acibadem Mehmet Ali Aydinlar University School of Medicine, Istanbul, Turkey

    Umit Aksoy Ozcan & Ozden S. Ulus

  29. Department of Radiological, Oncological and Pathological Sciences, Sapienza University of Rome, Rome, Italy

    Federica Pediconi

  30. Department of Diagnostic and Interventional Radiology, University Hospital of Tübingen, Tübingen, Germany

    Heike Preibsch

  31. Deparment of Radiology, Hospital Universitario Reina Sofía, Córdoba, Spain

    José L. Raya-Povedano

  32. Kiwifarm Srl, La Morra, Italy

    Daniela Sacchetto

  33. Disaster Medicine Service 118, ASL CN1, Saluzzo, Italy

    Daniela Sacchetto

  34. CRIMEDIM, Research Center in Emergency and Disaster Medicine, Università del Piemonte Orientale, Novara, Italy

    Daniela Sacchetto

  35. Department of Surgery, Radboud University Medical Center, Nijmegen, The Netherlands

    Margrethe Schlooz

  36. Department of Radiology, Barking Havering and Redbridge University Hospitals NHS Trust, London, UK

    Botond K. Szabo

  37. Medical School, Faculty of Health and Medical Sciences, University of Western Australia, Perth, Australia

    Donna B. Taylor

  38. Department of Radiology, Royal Perth Hospital, Perth, Australia

    Donna B. Taylor

  39. Gynecological Oncology Unit, Department of Obstetrics and Gynecology, Department of Radiology, Multidisciplinary Breast Clinic, Antwerp University Hospital-University of Antwerp, Antwerp, Belgium

    Mireille Van Goethem

  40. Maatschap Radiologie Oost-Nederland, Oldenzaal, The Netherlands

    Jeroen Veltman

  41. Institute of Clinical Radiology and Reference Center for Mammography, University of Münster, Münster, Germany

    Stefanie Weigel

  42. Department of Radiology, University Hospital of Erlangen, Erlangen, Germany

    Evelyn Wenkel

Authors
  1. Francesco Sardanelli
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  2. Rubina M. Trimboli
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  3. Nehmat Houssami
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  4. Fiona J. Gilbert
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  5. Thomas H. Helbich
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  6. Marina Alvarez Benito
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  7. Corinne Balleyguier
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  8. Massimo Bazzocchi
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  9. Peter Bult
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  10. Massimo Calabrese
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  11. Julia Camps Herrero
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  12. Francesco Cartia
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  13. Enrico Cassano
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  14. Paola Clauser
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  15. Danubia A. de Andrade
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  16. Marcos F. de Lima Docema
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  17. Catherine Depretto
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  18. Gabor Forrai
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  19. Rossano Girometti
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  20. Steven E. Harms
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  21. Sarah Hilborne
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  22. Raffaele Ienzi
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  23. Marc B. I. Lobbes
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  24. Claudio Losio
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  25. Ritse M. Mann
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  26. Stefania Montemezzi
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  27. Inge-Marie Obdeijn
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  28. Umit Aksoy Ozcan
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  29. Federica Pediconi
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  30. Heike Preibsch
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  31. José L. Raya-Povedano
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  32. Daniela Sacchetto
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  33. Gianfranco P. Scaperrotta
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  34. Margrethe Schlooz
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  35. Botond K. Szabo
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  36. Ozden S. Ulus
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  37. Donna B. Taylor
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  38. Mireille Van Goethem
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  39. Jeroen Veltman
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  40. Stefanie Weigel
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  41. Evelyn Wenkel
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  42. Chiara Zuiani
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  43. Giovanni Di Leo
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Corresponding author

Correspondence to Francesco Sardanelli.

Ethics declarations

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.

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One of the authors has significant statistical expertise.

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

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Institutional Review Board approval was obtained.

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• 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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