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Magnetic Resonance Imaging (MRI) of Tumor Response and Cognitive Impairment in Breast Cancer Patients Undergoing Chemotherapy

2012年4月4日 更新者:Kettering Health Network

Magnetic Resonance Imaging of Tumor Response and Cognitive Impairment in Breast Cancer Patients Undergoing Anthracycline-based Systemic Chemotherapy

We will use magnetic resonance imaging (MRI) to investigate tumor changes in women with breast cancer who are receiving anthracycline-based systemic chemotherapy. We will also use MRI and cognitive tests to study the possible effects of chemotherapy on the brains of these women. The results will be compared to a control group of normal healthy women. We will try to determine if MRI can be used to predict tumor response and cognitive changes related to the chemotherapy.

研究概览

地位

撤销

条件

详细说明

In this work we will utilize conventional magnetic resonance imaging as well as a set of advanced magnetic resonance imaging tools to investigate changes in tumor physiology and the human brain resulting from anthracycline-based systemic chemotherapy. We will recruit up to 15 subjects diagnosed with breast cancer and preparing for an anthracycline-based systemic chemotherapy regimen. Each subject will undergo the set of MR imaging tools before therapy, after one therapy session, after four therapy sessions, and at the conclusion of therapy. Conventional MRI methods will be used to quantify tumor-response to chemotherapy for each subject. A control group of up to 15 normal subjects will also be recruited and will undergo MR brain imaging twice with a gap of 6 months between scans. All subjects will also undergo a battery of neuropsychological tests at each imaging session. The results of the neuropsychological tests will be used to quantify cognitive changes for each subject. A final analysis will determine if the advanced MR modalities can be used to predict the response of tumors or human cognition to chemotherapy.

研究类型

观察性的

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

    • Ohio
      • Dayton、Ohio、美国、45408
        • Medical Oncology Hematology Associates, Inc
      • Kettering、Ohio、美国、45429
        • Innovation Center, Kettering Health Network

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

18年 至 65年 (成人、年长者)

接受健康志愿者

是的

有资格学习的性别

女性

取样方法

非概率样本

研究人群

Breast cancer cohort will be patients of Medical Oncology Hematology Associates Inc., Dayton, OH

Normal controls will be recruited from Kettering College of Medical Arts and the Kettering Health Network.

描述

Inclusion Criteria:

  • Diagnosed with Adenocarcinoma(ER+ve, PR+ve)
  • Prescribed, but not yet begun, anthracycline based systemic chemotherapy
  • Not prescribed Avastin
  • Able to read and write in English
  • Have signed informed consent

Exclusion Criteria:

  • Diagnosed psychiatric disorder
  • Conditions that would preclude MRI (Pacemaker, metal objects in body, claustrophobia, pregnancy, etc.)
  • Serious, unstable medical or mental illness
  • Medical contraindication to any study procedure
  • Current alcohol or other substance use disorder (excluding nicotine)
  • Have not read and signed informed consent, or do not understand its contents

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

队列和干预

团体/队列
Breast cancer, chemotherapy
Up to 15 women with breast cancer who are to undergo systemic anthracycline based chemotherapy.
Normal control
Up to 15 normal, healthy women.

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。

调查人员

  • 首席研究员:Jason Parker, PhD、Kettering Health Network

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

2009年12月1日

初级完成 (实际的)

2011年10月1日

研究完成 (实际的)

2011年10月1日

研究注册日期

首次提交

2010年1月6日

首先提交符合 QC 标准的

2010年1月7日

首次发布 (估计)

2010年1月8日

研究记录更新

最后更新发布 (估计)

2012年4月5日

上次提交的符合 QC 标准的更新

2012年4月4日

最后验证

2012年4月1日

更多信息

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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