Purpose@#
Detection of multifocal, multicentric, and contralateral
breast cancers in
patients affects surgical management. Dynamic contrast-enhanced
magnetic resonance imaging (DCE-MRI) can identify additional foci that were initially undetected by conventional imaging. However, its use is limited owing to low
specificity and high false-positive rate.
Multiparametric MRI (DCE-MRI +
diffusion -weighted [DW] MRI) can increase the
specificity . We aimed to describe the
protocols of our prospective, multicenter, observational
cohort studies designed to compare the diagnostic performance of DCE-MRI and
multiparametric MRI for the
diagnosis of multifocal, multicentric
cancer and contralateral
breast cancer in
patients with newly diagnosed
breast cancer . @*
Methods @#Two studies comparing the performance of DCE-MRI and
multiparametric MRI for the
diagnosis of multifocal, multicentric
cancer (NCT04656639) and contralateral
breast cancer (NCT05307757)
will be conducted. For trial NCT04656639, 580
females with invasive
breast cancer candidates for
breast conservation
surgery whose DCE-MRI showed additional suspicious lesions (
breast imaging
reporting and data system [BI-RADS] category ≥ 4) on DCE-MRI in the ipsilateral
breast will be enrolled. For trial NCT05307757, 1098
females with invasive
breast cancer whose DCE-MRI showed contralateral lesions (BI-RADS category ≥ 3 or higher on DCE-MRI)
will be enrolled. Participants
will undergo 3.0-T DCE-MRI and DWMRI. The diagnostic performance of DCE-MRI and
multiparametric MRI will be compared.The
receiver operating characteristic curve,
sensitivity ,
specificity ,
positive predictive value , and characteristics of the detected
cancers will be analyzed. The primary outcome is the difference in the
receiver operating characteristic curve between DCE-MRI and
multiparametric MRI interpretation. Enrollment completion is expected in 2024, and study results are expected to be presented in 2026.
Discussion: This prospective,
multicenter study will compare the performance of DCE-MRI versus
multiparametric MRI for the preoperative evaluation of multifocal, multicentric, and contralateral
breast cancer and is currently in the
patient enrollment phase.