Diffusion-Weighted Magnetic Resonance Imaging for Preoperative Evaluation of Patients With Breast Cancer: Protocol of a Prospective, Multicenter, Observational Cohort Study

박영진; 신희정; 강봉주; 김민정; 문우경; 송성은; 하수민

doi:10.4048/jbc.2023.26.e18

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저자정보: 박영진 (Department of Radiology Severance Hospital Research Institute of Radiological Science Yonsei University College of Medicine Seoul Korea.) 신희정 (Department of Radiology Asan Medical Center University of Ulsan College of Medicine Seoul Korea.) 강봉주 (Department of Radiology Seoul St. Mary’s Hospital College of Medicine The Catholic University of Korea Seoul Korea.) 김민정 (Department of Radiology Severance Hospital Research Institute of Radiological Science Yonsei University College of Medicine Seoul Korea) 문우경 (Department of Radiology Seoul National University Hospital Seoul Korea.Department of Radiology Seoul National University College of Medicine Seoul Korea.Institute of Radiation Medicine Seoul National) 송성은 (Department of Radiology Korea University Hospital Korea University College of Medicine Seoul Korea.) 하수민 (Department of Radiology Seoul National University Hospital Seoul Korea.Department of Radiology Seoul National University College of Medicine Seoul Korea.)

저널정보: 한국유방암학회 Journal of Breast Cancer Journal of Breast Cancer Vol.26 No.3

발행연도: 2023.6

수록면: 292 - 301 (10page)

DOI: 10.4048/jbc.2023.26.e18

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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.

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.

#Breast Neoplasms #Clinical Trial #Multicenter Studies as Topic #Multiparametric Magnetic Resonance Imaging

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박영진

소속기관 Department of Radiology, Severance Hospital, Research Institute of Radiological Science, Yonsei University College of Medicine, Seoul, Korea.

주요연구분야 의약학 > 임상의학 > 일반 외과학

논문수 4 이용수 2

신희정

소속기관 Department of Radiology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.

주요연구분야 의약학 > 임상의학 > 일반 외과학

논문수 10 이용수 2

강봉주

소속기관 Department of Radiology, Seoul St. Mary’s Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea.

주요연구분야 의약학 > 임상의학 > 일반 외과학

논문수 6 이용수 3

김민정

소속기관 Department of Radiology, Severance Hospital, Research Institute of Radiological Science, Yonsei University College of Medicine, Seoul, Korea

주요연구분야 의약학 > 의학 일반 자연과학 > 생물학

논문수 16 이용수 52

문우경

소속기관 Department of Radiology, Seoul National University Hospital, Seoul, Korea.Department of Radiology, Seoul National University College of Medicine, Seoul, Korea.Institute of Radiation Medicine

주요연구분야 의약학 > 임상의학 > 일반 외과학

논문수 13 이용수 3

송성은

소속기관 Department of Radiology, Korea University Hospital, Korea University College of Medicine, Seoul, Korea.

주요연구분야 의약학 > 의학 일반 의약학 > 임상의학 > 일반 외과학

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하수민

소속기관 Department of Radiology, Seoul National University Hospital, Seoul, Korea.Department of Radiology, Seoul National University College of Medicine, Seoul, Korea.

주요연구분야 의약학 > 임상의학 > 일반 외과학

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