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临床试验/NCT04656639
NCT04656639招募中不适用

Diffusion-Weighted MRI for Diagnosis of Multifocal, Multicentric Breast Cancer

Seoul National University Hospital1 个研究点 分布在 1 个国家目标入组 580 人开始时间: 2022年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
580
试验地点
1
主要终点
Receiver operating characteristic per lesion and breast level

研究概览

简要总结

Detection of multifocal, multicentric breast cancer in patients with breast cancer affects surgical decision. Histology-proven additional cancer foci have been reported to be detected in 21.0% to 63.0% of affected breasts in women thought to have localized cancer based on clinical assessment and mammography. Dynamic contrast-enhanced (DCE) MRI is often applied in the preoperative local staging of breast cancer due to its high sensitivity and identifies additional foci that would have otherwise remained undetected on clinical assessment and conventional imaging (mammography and ultrasonography). However, DCE MRI is limited in use due to its low specificity with high false positive rate, causing unnecessary and incorrect conversion to more extensive surgery. Diffusion-weighted MRI (DWI) is a fast, functional MRI technique that measures the movement of water molecules to create tissue contrast without the need for contrast injection. Breast malignancies exhibit hindered diffusion and appear hyperintense on DWI with low apparent diffusion coefficient (ADC) values compared to normal surrounding tissue or benign tumors. Multiple studies including one prospective multi-center trial showed that DWI can reduce unnecessary benign biopsies of suspicious mammographic or DCE MRI-detected lesions and DWI is now considered as an important part of multi-parametric breast MRI protocols. However, little is known about the role of DWI as an adjunct to DCE MRI in the local staging of women with breast cancer. The purpose of our study is to determine whether DWI improves the performance of preoperative DCE MRI in the evaluation of additional lesions in breast cancer patients.

详细描述

Primary objective: to compare the diagnostic performance of DCE MRI vs combination of DWI and DCE MRI for detection of multifocal, multicentric breast cancer in patients planning for breast conservation surgery

Detailed Description

  • This is a multicenter, intraindividual comparative cohort study.
  • A total of 580 women with newly diagnosed breast cancer will be enrolled in this study.
  • Each eligible woman with newly diagnosed invasive breast cancer will undergo DCE MRI and DWI at a 3T MR scanner.
  • Contrast-enhanced MRI and DWI will be interpreted independently according to the Breast Imaging Reporting and Data System (BI-RADS) and likelihood of malignancy (Score range, 0%-100%) by trained radiologists.
  • Multifocal breast cancer is defined as presence of more than 2 separate (≥1.0cm) foci of breast cancer in the same quadrant or within 5 cm of the primary lesion.
  • Multicentric cancer is defined as two or more synchronous ipsilateral neoplasm located in different quadrant or beyond 5 cm from the primary lesion.
  • BI-RADS final assessment score of 4 or 5 are considered to be positive.
  • Pathology of core or surgical biopsy and 2 year follow up is the reference standard.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
25 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Women aged more than 25 years at the time of enrollment
  • Women underwent digital mammography and whole-breast US before MRI
  • Women with image-guided biopsy result of invasive breast cancer
  • Women who are planning for breast conservation surgery
  • Women who will undergo preoperative breast MRI

排除标准

  • Women aged less than 25 years at the time of enrollment
  • Women with image-guided biopsy result of ductal carcinoma in situ or recurrent breast cancer
  • Women who underwent lumpectomy before MRI
  • Women receiving neoadjuvant chemotherapy or undergoing chemotherapy due to other malignancy
  • Pregnant or lactating women
  • Women with contraindication to breast MRI (claustrophobia, renal insufficiency GFR <60mL/min/1.73m2, metallic foreign body, history of severe side effects due to MR contrast agent, who cannot tolerate 40 minute scanning time etc).

结局指标

主要结局

Receiver operating characteristic per lesion and breast level

时间窗: 2 year after enrollment

Area under the curve (AUC)

次要结局

  • Specificity per lesion and breast level(2 year after enrollment)
  • Sensitivity per lesion and breast level(2 year after enrollment)
  • Characteristics of detected cancers(2 year after enrollment)
  • Positive Predictive value per lesion and breast level(2 year after enrollment)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Woo Kyung Moon

Professor

Seoul National University Hospital

研究点 (1)

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