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Pre-operative Magnetic Resonance Imaging (MRI) in Young Breast Cancer Patients

2009年11月17日更新者：McMaster University

A Prospective Cohort Study to Evaluate the Impact of Preoperative Breast Magnetic Resonance Imaging (MRI) on Surgical Decision-Making in Young Patients With Breast Cancer

Young women with breast cancer have an increased breast tissue density and conventional imaging tests such as mammography and breast ultrasound are less sensitive and specific for detecting breast cancer than in older breast cancer patients. Breast MRI is an emerging tool that has been proven to improve the ability to identify breast cancers by determining the extent of disease and also detect multifocal, multicentric and bilateral breast cancers. To date, the role of pre-operative breast MRI is not clearly defined. The investigators are proposing a study to evaluate the impact of preoperative breast MRI on surgical decision-making in breast cancer patients <= 50 years. This may lead to improved characterization of breast cancers in these younger patients that may ultimately result in lower local recurrence rates in the future. The additional information attained through the breast MRI may also guide the use of radiation, chemotherapy and/or hormonal therapy in these patients.

研究概览

地位

未知

条件

干预/治疗

程序：Pre-operative bilateral breast MRI

详细说明

Inclusion Criteria:

female aged ≤ 50
histologically proven invasive breast cancer

Exclusion Criteria:

Is not considered a surgical candidate
Has had prior breast cancer surgery or an excisional biopsy of the newly diagnosed lesion
Has a contraindication to undergoing breast MRI
Has inflammatory breast cancer according to the standard clinical definition
Has locally advanced breast cancer according to the standard clinical definition
Patient is pregnant
Has a psychiatric or addictive disorder that would preclude obtaining informed consent or adherence to the protocol

研究类型

介入性

注册 (预期的)

阶段

不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

加拿大
- Ontario
  - Hamilton、Ontario、加拿大、L8V 5C2
    - 招聘中
    - Juravinski Cancer Centre
    - 首席研究员：
      
      Nicole Hodgson, MD
  - Hamilton、Ontario、加拿大、L8N 4A6
    - 招聘中
    - St. Josephs' Healthcare
    - 接触：
      
      Sylvie Cornacchi
      
      电话号码：905-521-6060
      
      邮箱：cornacs@mcmaster.ca
    - 首席研究员：
      
      Peter Lovrics, MD
    - 副研究员：
      
      Barbara Heller, MD

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

不超过 50年 (孩子、成人)

接受健康志愿者

不

有资格学习的性别

女性

描述

Inclusion Criteria:

Female aged <= 50 years
Histological proof of invasive breast cancer via fine needle aspiration or core needle biopsy
Premenopausal

Exclusion Criteria:

Patient not considered an appropriate surgical candidate; i.e., patient is not well enough to have breast cancer surgery
Patient has had prior breast cancer surgery or an excisional biopsy of the newly diagnosed cancer
Patient has a contraindication to undergoing breast MRI (i.e., pacemaker, neurodefibrillator, metallic foreign bodies, etc.)
Patient has inflammatory breast cancer according to the standard clinical definition. This is a type of breast cancer in which there is evidence of erythema and/or edema. The skin of the breast may also have changes of peau d'orange.
Patient has locally advanced breast cancer according to the standard clinical definition.
Patient is pregnant
Patient has a psychiatric or addictive disorder that would preclude them from obtaining informed consent.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

主要用途：诊断
分配：非随机化
介入模型：单组作业
屏蔽：无（打开标签）

研究衡量的是什么？

主要结果指标

结果测量	大体时间
Does pre-operative magnetic resonance imaging (MRI) effect surgical management in young women with breast cancer 大体时间：3 months	3 months

次要结果测量

结果测量	大体时间
Proportion of patients requiring a second surgery due to positive tumour margins. 大体时间：3 months	3 months
Incidence of multifocal or multicentric or bilateral breast cancer found on MRI 大体时间：After surgery	After surgery
The correlation between MRI tumour size and the pathologic tumour size after surgery. 大体时间：3 months	3 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

McMaster University

调查人员

首席研究员：Nicole Hodgson, MD、Juravinski Cancer Centre
首席研究员：Som D Mukherjee, MD、Juravinski Cancer Centre

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2008年4月1日

初级完成 (预期的)

2009年12月1日

研究完成 (预期的)

2010年5月1日

研究注册日期

首次提交

2008年12月2日

首先提交符合 QC 标准的