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.

Preoperative Staging in Breast Cancer: Intraindividual Comparison of Unenhanced MRI Combined With Digital Breast Tomosynthesis and Dynamic Contrast Enhanced-MRI

“…Despite several studies have progressively promoted the role of breast MRI to complete conventional imaging for preoperative staging, due to evidence-based benefits, the limited number of randomized clinical trials (22)(23)(24)(25)(26) that evaluated the impact of preoperative MRI on treatment regimens and surgical outcomes have given conflicting results. A large-scale observational multicenter prospective study (MIPA study) was launched internationally in 2012 but is currently at the analytic phase (27). As a consequence, the role of preoperative breast MRI remains controversial for now, and alternative imaging modalities have been considered to evaluate the extent of disease during the preoperative planning.…”

Breast cancer surgery with augmented reality

“…Preoperative contrast-enhanced breast MRI has emerged as a solution, but neither the COMICE [ 13 ] nor the MONET [ 14 ] trial found an associated benefit. Additional studies are needed to further exploit additional MRI information and techniques to be applied in the surgical theater [ 15 ]. Intraoperative US (as an additional tool to standard localization techniques) has been used successfully to some extent to reduce positive margins, therefore reducing re-operation rates [ 16 , 17 ].…”

The effect of breast MRI on disease-free and overall survival in breast cancer patients: a retrospective population-based study

“…Future studies should investigate the effect on prognosis by comparing patients in whom MRI findings led to a change in treatment plan with those without treatment change and/or patients without MRI. For instance, the currently recruiting European wide MIPA trial could identify this specific subgroup of patients allowing to investigate prognosis in these patients into detail [ 20 ].…”