Abstract
BackgroundCorrect preoperative estimation of the malignant extent is crucial for optimal planning of breast cancer surgery. The sensitivity of mammography is lower in dense breasts, and additional imaging techniques are sometimes warranted. Contrast-enhanced mammography (CEM) has shown similar sensitivity and in some cases better specificity, than magnetic resonance imaging (MRI) in small, observational studies. CEM may be more cost-effective than MRI, and may provide better identification of the tumor extent, however, no randomized trials have been performed to date to investigate the added value of CEM.In a feasibility study, we found that the treatment was changed in 10/47 (21%) cases after additional CEM. The purpose of the present study is to evaluate the added value of CEM in preoperative staging of breast cancer in a randomized study.MethodThis prospective randomized study will include 440 patients with strongly suspected or established diagnosis of breast malignancy, based on assessment with mammography, ultrasound and core biopsy/cytology, and for whom primary surgery is planned. Patients will be randomized 1:1 using a web-based randomization tool to additional investigation with CEM or no further imaging. The CEM findings will be taken into consideration, which may lead to changes in primary treatment, which is the primary endpoint of this study. Secondary endpoints include rate of reoperation and number of avoidable mastectomies, as well as a cost-benefit analysis of additional CEM. Patient-reported health-related quality of life will be investigated at 1 year with the validated Breast-Q™ questionnaire. The rate of local recurrence or new cancer ipsi- or contralaterally within 5 years will be assessed from medical records and pathology reports.DiscussionThe aim of this trial is to explore the added value of CEM in preoperative staging of breast cancer. The results obtained from this study will contribute to our knowledge on CEM as an additional imaging method to standard investigation with digital mammography and ultrasound. The findings may also provide additional information on which patient groups would benefit from CEM, and on the economic aspects of CEM in standard preoperative practice.Trial registrationThis trial is registered at clinicaltrials.gov, registration no: NCT04437602, date of registration: June 18, 2020.
Highlights
Correct preoperative estimation of the malignant extent is crucial for optimal planning of breast cancer surgery
The results obtained from this study will contribute to our knowledge on Contrast-enhanced mammography (CEM) as an additional imaging method to standard investigation with digital mammography and ultrasound
The findings may provide additional information on which patient groups would benefit from CEM, and on the economic aspects of CEM in standard preoperative practice
Summary
Correct preoperative estimation of the malignant extent is crucial for optimal planning of breast cancer surgery. Contrast-enhanced mammography (CEM) has shown similar sensitivity and in some cases better specificity, than magnetic resonance imaging (MRI) in small, observational studies. CEM may be more costeffective than MRI, and may provide better identification of the tumor extent, no randomized trials have been performed to date to investigate the added value of CEM. The purpose of the present study is to evaluate the added value of CEM in preoperative staging of breast cancer in a randomized study. Regardless of the method of detection, “triple assessment” should be performed. This includes clinical examination, breast imaging, and cytological or histological investigation to determine whether the finding is malignant or benign. The sensitivity of diagnostic mammography is known to be lower in breasts of high density [2, 3], in younger patients [2, 4], and for lobular breast cancer [5]
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