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临床试验/NCT00291304
NCT00291304终止2 期

Magnetic Resonance Imaging (MRI) Correlation to Standard of Care Imaging and Pathology Correlation in Breast Carcinoma

AHS Cancer Control Alberta2 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2006年3月最近更新:
适应症

试验速览

阶段
2 期
状态
终止
入组人数
72
试验地点
2
主要终点
-assess how MRI of the breast correlates to standard of care which includes ultrasound, mammography, biopsy and surgery

研究概览

简要总结

Magnetic Resonance Imaging (MRI) is a well known imaging tool for the investigation and diagnosis of breast cancer, used in addition to breast mammograms and ultrasound. Recent publications suggest that MRI may be the best test to use in women who have very dense breasts, have a family history of breast cancer and have had breast cancer and were treated with breast saving measures. MRI has been shown to be a better tool to show multiple breast cancer spots than mammography or ultrasound. The radiologists and the radiology students will have the opportunity to review the MRI scans along with the breast ultrasound and mammography films and the pathology reports from the breast cancer surgery completed at the CCI. This may enable them to learn how the various subtypes of breast cancer look on MRI. The goal is: 1) to gain good breast MRI expertise, giving the Radiology residents a complete diagnostic program. 2) to develop good MRI breast experience, enabling the Cross Cancer Institute to be the centre of excellence for Breast MRI for northern Alberta.

详细描述

Background Information

In addition to the gold standard imaging of mammography and breast ultrasound, magnetic resonance imaging (MRI) has become a well established investigational modality for the diagnosis and staging of breast cancer. MRI demonstrates increased sensitivity and specificity relative to both mammography and breast ultrasound in the screening of women with an increased risk of breast cancer development (i.e. familial history of disease and / or genetic predisposition) and those who have very dense breast tissue. MRI has also proved to be very sensitive in the detection of multi-focal, multi-centric breast lesions, permitting the accurate staging of disease. However, despite this demonstrated efficacy, the standardization of MRI studies from one Institution to another is often difficult as each Institution will have a standard breast protocol with sequences set in accordance to the manufacturer of the machine and the manner in which the breast examinations have been designed.

At the Cross Cancer Institute (CCI) a breast MRI protocol based on the technical procedures recommended in the literature and personal scanning experience has been developed. However, due to the limited number of patients undergoing breast MRI examinations, our current experience is limited relative to the level of expertise demonstrated in the interpretation of breast ultrasound and mammographic scans. Fortunately, we now have the opportunity to obtain MRI - pathology correlation as Dr. Kelly Dabbs is performing on site breast cancer surgery at the CCI. We propose to obtain an MRI examination of all consented patients prior to their surgical procedure. The MRI results of each patient will then be compared to previous breast imaging (mammography and breast ultrasound) and histopathological specimens to determine the correlative accuracy of MRI with these techniques. To assess whether the size, grade, and presence of lymphovascular invasion or associated ductal carcinoma in situ influence the accuracy of MR imaging, all breast carcinoma subtypes will be included in this study.

As a teaching hospital, the CCI provides mammographic and breast ultrasound training to the Residents and the Diagnostic Radiology Program at the University of Alberta. Although breast MRI should be part of this training program, we currently do not have the necessary volume of breast MRI scans to provide Residents with adequate experience in this modality. The establishment of a breast MRI protocol, one which refers eligible CCI breast cancer patients for a pre-surgery MRI examination, will promote the development of expertise in this area, provide Residents with a comprehensive Breast program and keep the CCI at the leading edge of breast cancer care.

Objectives

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

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

入选标准

  • females 18 years or older
  • females referred to Dr. Kelly Dabbs for breast cancer surgery with pathology positive for breast carcinoma, any subtype

排除标准

  • pacemakers
  • aneurysm clips
  • cochlear implants
  • epicardial pacemaker wires
  • neural stimulators, etc.
  • significant claustrophobia
  • significant obesity that would not enable the patient to fit in the scanner
  • pregnancy or breast feeding

结局指标

主要结局

-assess how MRI of the breast correlates to standard of care which includes ultrasound, mammography, biopsy and surgery

时间窗: 2 years

次要结局

  • -assess how the MRO correlates to the breast cancer pathology collected at the CCI(2 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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