跳至主要内容
临床试验/NCT01837563
NCT01837563终止不适用

Monitoring of Neoadjuvant Therapy in Locally-Advanced Breast Cancer

Dartmouth-Hitchcock Medical Center1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2006年9月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
36
试验地点
1
主要终点
Objective Response

研究概览

简要总结

The purpose of this study is to determine whether four new alternative imaging methods can be used to follow the response of breast cancer to the treatment patients are being given. These methods produce an image of the inside of the breast so that doctors can better decide whether breast cancer is responding to therapy. An important part of the study is to examine the same person with all methods in order to directly compare results. The four methods are: MRI Elasticity Imaging (abbreviated MRE), Electrical Impedance Spectroscopy (abbreviated EIS), Microwave Imaging and Spectroscopy (abbreviated MIS), Near Infrared Spectroscopy (abbreviated NIR). In addition to the experimental imaging methods, patients may also undergo a contrast-enhanced MRI, and/or additional mammography, which will help researchers compare the experimental methods. These additional examinations are accepted diagnostic procedures; they are not experimental. Some participants will have one or both of these additional examinations if clinically indicated.

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

入选标准

  • Locally advanced breast cancer, with or without metastatic disease
  • Patient to receive systemic therapy
  • Breast size and epithelial integrity adequate to allow alternate imaging exams.
  • Patient able to provide written informed consent.
  • No serious associated psychiatric illness
  • Age ≥ 18 years old

排除标准

  • Cardiac pacemaker
  • Any implanted electronic device
  • Severe claustrophobia
  • Allergy to the MRI contrast agent gadolinium

结局指标

主要结局

Objective Response

时间窗: at baseline, at conclusion of treatment (up to 6 months)

Correlate changes in each imaging modality with objective response to therapy, as defined by conventional criteria (clinical exam and conventional imaging).

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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