跳至主要内容
临床试验/NCT00579319
NCT00579319撤回不适用

Use of Breast MRI for Local Staging

University of Arkansas0 个研究点开始时间: 2005年4月最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
主要终点
Breast MRI will have a significant impact on patient management

研究概览

简要总结

When breast MRI is used to determine the extent of local disease, the management changes, resulting in improved outcomes. Studies have indicated that breast MRI plus mammography is better for detecting tumors. surgeons are now utilizing breast MRI to determine the extent of disease in women diagnosed with breast cancer. It has not been established how management of breast cancer patients has been affected by the use of breast MRI or how that management has affected the outcome for these patients. This retrospective chart review will document management and outcome for breast cancer patients who have had pre treatment breast MRI.

详细描述

When breast MRI is used to determine the extent of local disease, the management changes, resulting in improved outcomes. Studies have indicated that breast MRI plus mammography is better for detecting tumors. surgeons are now utilizing breast MRI to determine the extent of disease in women diagnosed with breast cancer. It has not been established how management of breast cancer patients has been affected by the use of breast MRI or how that management has affected the outcome for these patients. This retrospective chart review will document management and outcome for breast cancer patients who have had pre treatment breast MRI.

The medical records of patients who received breast MRI for pre-treatment staging of breast cancer will be retrospectively reviewed to see if the MRI information affected management. UAMS surgeons will be asked if the breast MRI resulted in:

  1. no change in management
  2. Moderate change in management-what (modified lumpectomy-larger or smaller)
  3. Significant change-what (contralateral breast, additional quadrants, lump to mast, neoadjuvant chemo)-note less dz than w/o MRI, more dz than w/o MRI. The medical record of patients who were imaged will be reviewed for presenting symptom, clinical exam, imaging studies (mammogram, breast ultrasound, breast MRi) and pathology results. This study is limited to retrospective chart review with the only foreseeable risk being that of disclosure of PHI. To minimize this risk, data collection forms will be identified by subject ID number. A master list of these ID numbers linked to subject medical record number will be maintained in the investigator's file and kept in a secure location accessible only to the study team for purposes of verification of data and validation of results. The medical record number will not be recorded on any other form containing subject PHI. The only foreseeable breach of confidentiality would be for the security of the investigator's files to be compromised.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Retrospective

入排标准

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

入选标准

  • Patients who have undergone a breast MRI for staging

排除标准

  • 未提供

结局指标

主要结局

Breast MRI will have a significant impact on patient management

时间窗: at time of staging

次要结局

未报告次要终点

研究者

申办方类型
Other

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