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临床试验/NCT04619186
NCT04619186暂停不适用

Comparison of Diffusion-Weighted MRI and Mammography Alone or Combined Mammography and Ultrasonography for Screening Women With a Personal History of Breast Cancer (DIMRISC-2 Study)

Seoul National University Hospital1 个研究点 分布在 1 个国家目标入组 1,694 人开始时间: 2024年12月30日最近更新:
适应症

试验速览

阶段
不适用
状态
暂停
入组人数
1,694
试验地点
1
主要终点
Cancer detection rate (CDR)

研究概览

简要总结

Women with personal history of breast cancer (PHBC) are at risk of developing second breast cancers in the conserved and contralateral breast. Because early detection of second breast cancers at the asymptomatic phase can improve relative survival by 17-28%, guidelines recommend annual mammography screening in women with PHBC. However, lower sensitivity and higher interval cancer rates are observed in women with a PHBC compared with women without, especially in women 50 years or younger and those with dense breasts. In a multicenter comparison study of 754 women, MRI screening detected 3.8 additional cancers and ultrasonography detected 2.4 additional cancers, and increased sensitivity over mammography alone. However, the use of breast MRI is limited not only by high costs and long examination time but also by high false-positive findings. In addition, the use of intravenous gadolinium-based contrast agent is contraindicated in women with renal impairment or contrast material allergy contrast. Supplemental ultrasonography in patients with PHBC reports lower sensitivity with high interval cancer rate. Thus, there is a need to develop a more safe, accurate, and cost-effective supplemental imaging modality for screening in women with PHBC. Diffusion-weighted (DW) MRI is an unenhanced fast, functional modality that measures the movement of water molecules to create tissue contrast. Breast malignancies exhibit hindered diffusion and appear hyperintense on DW MRI with low apparent diffusion coefficient (ADC) compared to normal surrounding tissue. Multiple studies have shown that the use of DW MRI can significantly reduce the false positives and unnecessary benign biopsy of breast MRI. Several studies have shown that DW MRI has a potential to detect mammography occult breast cancers with less false positives compared to ultrasonography. These observations have led to the consideration of utilizing DW MRI to screen women with PHBC. In Diffusion-weighted MRI for Breast Cancer Screening (DIMRISC-2) study, we hypothesized that the screening performance of high-resolution DW MRI at 3.0 T should be superior to mammography alone or combined mammography and ultrasonography in women with PHBC. In our institution, alternating conventional imaging and DW MRI screening is offered for patients who have undergone breast surgery and at increased risk of an interval second breast cancer.

详细描述

  • Primary objective: to compare the screening performance of DW MRI versus mammography alone or combined mammography and ultrasonography in women with PHBC.
  • Secondary objective: to compare the tumor and patient characteristics detected by DW MRI and combined mammography and ultrasonography in women with PHBC.
  • This is a prospective, single center, observational cohort study.
  • A total of 1694 women will be enrolled in this study.
  • Two latest 3.0 T MRI scanners with dedicated 16- or 18-channel bilateral breast coil are used for DW MRI. For DW MRI screening, the high-resolution echo-planar imaging sequence is designed to have an in-plane resolution of 1.3 x 1.3 mm and a slice thickness of 3 mm. Three b values of 0, 800, and 1200 sec/mm2 are used and ADC maps are generated based on the b=0 and 800 sec/mm2 DW MRI data. The DW MRI images are reconstructed into single summation images with maximum-intensity projections (MIPs) in the sagittal and axial planes. In addition, T1-weighted imaging sequence is also obtained with in-plane resolution of 1.0 x 1.0 mm and a slice thickness of 1 mm.
  • All patients with PHBC undergo digital two-dimensional mammography and physician-performed whole-breast ultrasonography on the same day. DW MRI and conventional imaging (mammography and ultrasonography) are alternatively scheduled at 6-month intervals and the order has been randomized.
  • Mammography alone, combined mammography and ultrasonography, and DW MRI 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. DW MRI interpretation guidelines to be used in this study are based on both qualitative and quantitative assessments. Radiologists are required to successfully complete a training case series of 100 DW MR studies prior to interpreting the DW MRI.
  • A negative examination result is defined as a final assessment BI-RADS category of 1, 2, 3 and a positive examination result is defined as a final assessment BI-RADS category of 4 or 5.
  • Biopsies of DW MRI-detected lesions are performed under ultrasonography guidance whenever possible or with MR guidance if there is no correlative ultrasonography finding. Pathology of core or surgical biopsy and 1 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 over 25 years of age at the time of enrollment
  • Women who underwent breast conservation therapy or mastectomy and at increased risk of an interval second breast cancer (Age <50 at first cancer diagnosis; Breast density BI-RADS category 3 and 4; First degree family history; First breast cancer was an interval cancer or symptomatic presentation; First breast cancer was grade 2, 3 or ER and PR negative)

排除标准

  • Women with signs or symptoms of breast cancer
  • Women who had bilateral mastectomy
  • Women who had known metastatic disease
  • Pregnant or lactating women
  • Women with claustrophobia or metallic foreign body

结局指标

主要结局

Cancer detection rate (CDR)

时间窗: Baseline to up to 1 year

Number of detected cancers (invasive cancer and DCIS) /1000 women

次要结局

  • Characteristics of women with DW-MRI detected cancer(Baseline to up to 1 year)
  • Sensitivity(Baseline to up to 1 year)
  • Interval cancer rate(Baseline to up to 1 year)
  • Characteristics of detected cancers(Baseline to up to 1 year)
  • Specificity(Baseline to up to 1 year)
  • Positive predictive value (PPV)(Baseline to up to 1 year)
  • Recall rate(Baseline to up to 1 year)
  • Accuracy(Baseline to up to 1 year)

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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