Vivian Youngjean Park, Hee Jung Shin, Bong Joo Kang, Min Jung Kim, Woo Kyung Moon, Sung Eun Song, Su Min Ha
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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.</p><p><strong>Methods: </strong>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 DW-MRI. 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.</p><p><strong>Discussion: </strong>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.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov Identifier: NCT04656639, NCT05307757. 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引用次数: 0
摘要
目的:多灶、多中心和对侧乳腺癌患者的检测影响手术治疗。动态对比增强磁共振成像(DCE-MRI)可以识别常规成像最初未检测到的额外病灶。但由于特异性低、假阳性率高，其使用受到限制。多参数MRI (DCE-MRI +弥散加权[DW] MRI)可提高特异性。我们的目的是描述我们的前瞻性、多中心、观察性队列研究的方案，这些研究旨在比较DCE-MRI和多参数MRI在诊断新诊断乳腺癌患者的多灶、多中心癌症和对侧乳腺癌方面的诊断性能。方法:两项研究比较DCE-MRI和多参数MRI对多灶、多中心癌(NCT04656639)和对侧乳腺癌(NCT05307757)的诊断效果。在试验NCT04656639中，580名接受保乳手术的女性浸润性乳腺癌患者，其DCE-MRI在同侧乳房上显示额外的可疑病变(乳腺成像报告和数据系统[BI-RADS]分类≥4)。在试验NCT05307757中，1098名DCE-MRI显示对侧病变(DCE-MRI BI-RADS分类≥3或更高)的浸润性乳腺癌女性将入组。参与者将接受3.0 t DCE-MRI和DW-MRI检查。比较DCE-MRI和多参数MRI的诊断性能。分析受者工作特征曲线、敏感性、特异性、阳性预测值和检测到的癌症特征。主要结果是DCE-MRI和多参数MRI解释之间受试者工作特征曲线的差异。预计2024年完成入学，2026年公布研究结果。讨论:这项前瞻性的多中心研究将比较DCE-MRI与多参数MRI在多灶、多中心和对侧乳腺癌术前评估中的表现，目前正处于患者入组阶段。试验注册:ClinicalTrials.gov标识符:NCT04656639, NCT05307757。于2022年4月1日注册。
Diffusion-Weighted Magnetic Resonance Imaging for Preoperative Evaluation of Patients With Breast Cancer: Protocol of a Prospective, Multicenter, Observational Cohort Study.
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 DW-MRI. 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.
Trial registration: ClinicalTrials.gov Identifier: NCT04656639, NCT05307757. Registered on April 1 2022.
期刊介绍：
The Journal of Breast Cancer (abbreviated as ''J Breast Cancer'') is the official journal of the Korean Breast Cancer Society, which is issued quarterly in the last day of March, June, September, and December each year since 1998. All the contents of the Journal is available online at the official journal website (http://ejbc.kr) under open access policy. The journal aims to provide a forum for the academic communication between medical doctors, basic science researchers, and health care professionals to be interested in breast cancer. To get this aim, we publish original investigations, review articles, brief communications including case reports, editorial opinions on the topics of importance to breast cancer, and welcome new research findings and epidemiological studies, especially when they contain a regional data to grab the international reader''s interest. Although the journal is mainly dealing with the issues of breast cancer, rare cases among benign breast diseases or evidence-based scientifically written articles providing useful information for clinical practice can be published as well.
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