Rapid Access to Contrast-Enhanced spectral mammogRaphy in women recalled from breast cancer screening: the RACER trial study design

Abstract

BackgroundIn the Dutch breast cancer screening program, women recalled with a BI-RADS 0 score are referred for additional imaging, while those with BI-RADS 4/5 scores are also directed to an outpatient breast clinic. Approximately six out of ten women are recalled without being diagnosed with a malignancy. However, these recalls require additional imaging and doctor visits, which result in patient anxiety and increased health care costs. Conventional types of imaging used for additional imaging are full-field digital mammography and tomosynthesis. Contrast-enhanced spectral mammography has proved to have higher sensitivity and specificity than conventional imaging in women recalled from screening. Therefore, the aim is to study if CESM instead of conventional imaging is a more accurate, patient-friendly, and cost-effective strategy in the work-up of women recalled from breast cancer screening.MethodsThis prospective, multicenter, randomized controlled trial will be conducted at four centers and will include 528 patients recalled for suspicious breast lesions from the Dutch breast cancer screening program. Participants are randomized in two groups: (1) standard care using conventional breast imaging techniques as initial imaging after recall versus (2) work-up primarily based on CESM. Written informed consent will be collected prior to study inclusion. The primary outcome is the diagnostic accuracy for detection of breast cancer. Secondary outcomes are numbers of additional diagnostic exams, days until final diagnosis, health care costs, and experienced patient anxiety.DiscussionBased on previously published retrospective studies, we expect to demonstrate in this prospective multicenter randomized controlled trial, that using CESM as a primary work-up tool in women recalled from breast cancer screening is a more accurate, cost-effective, and patient-friendly strategy.Trial registration Netherlands Trial Register, NL6413/NTR6589. Registered on 6 July, 2017.

Contrast-enhanced mammography for the assessment of screening recalls: a two-centre study

“…Limitations of this study include—first—the only potential nature of the biopsy reduction we described and the non-randomised design: these characteristics prevented a clinical comparison of the SA and CEM-based work-up, also including patients’ preferences and cost-effectiveness, as will be done by the RACER trial [ 39 ]. Second, as already discussed for suspicious calcifications resulting in rCEM false negatives, our study design also factually oriented the analysis towards an appraisal of the contribution of rCEM information rather than of the “whole” CEM examination (low-energy and rCEM images).…”

Contrast-enhanced Mammography: State of the Art

“…Despite the success of CEM for the evaluation of abnormalities found at screening, most studies cited within this section are retrospective and considered only scenarios with a high prevalence of breast cancer. Prospective randomized clinical trials are underway to compare the work-up of women recalled with either conventional imaging or CEM (21).…”

Breast imaging: Beyond the detection

“…The most common indications for CEM are: inconclusive findings at conventional breast imaging, preoperative staging and monitoring of response to therapy. [19,20]…”