Department of Surgery, Halland Hospital, 301 85, Halmstad, Sweden.
Institution of Clinical Sciences, Department of Surgery, Lund University, Lund, Sweden.
BMC Cancer. 2021 Oct 18;21(1):1115. doi: 10.1186/s12885-021-08832-2.
Correct 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.
This 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.
The 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.
This trial is registered at clinicaltrials.gov , registration no: NCT04437602 , date of registration: June 18, 2020.
正确的术前恶性程度评估对于乳腺癌手术的最佳规划至关重要。在致密乳房中，乳房 X 线摄影的敏感性较低，有时需要额外的成像技术。与磁共振成像（MRI）相比，对比增强乳腺摄影（CEM）在小型观察性研究中具有相似的敏感性，在某些情况下具有更好的特异性。CEM 可能比 MRI 更具成本效益，并且可以更好地识别肿瘤范围，但是，迄今为止，尚无随机试验来研究 CEM 的附加价值。在一项可行性研究中，我们发现 47 例（21％）患者在进行额外的 CEM 后改变了治疗方案。本研究的目的是在一项随机研究中评估 CEM 在乳腺癌术前分期中的附加价值。
本前瞻性随机研究将包括 440 例强烈怀疑或确诊为乳腺癌的患者，这些患者基于乳房 X 线摄影、超声和核心活检/细胞学评估，计划进行原发性手术。患者将使用基于网络的随机化工具以 1：1 的比例随机分为 CEM 检查组或无进一步影像学检查组。将考虑 CEM 的检查结果，这可能导致原发性治疗的改变，这是本研究的主要终点。次要终点包括再次手术的发生率和可避免的乳房切除术的数量，以及 CEM 的成本效益分析。将使用经过验证的 Breast-Q™问卷在 1 年时调查患者报告的健康相关生活质量。将从病历和病理报告中评估 5 年内同侧或对侧局部复发或新发癌症的发生率。
本试验的目的是探讨 CEM 在乳腺癌术前分期中的附加价值。该研究的结果将有助于我们了解 CEM 作为数字乳房 X 线摄影和超声标准检查的附加成像方法。这些发现还可能提供有关哪些患者群体将从 CEM 中受益以及 CEM 在标准术前实践中的经济方面的更多信息。
该试验在 clinicaltrials.gov 注册，注册号：NCT04437602，注册日期：2020 年 6 月 18 日。
