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Feasibility of Blood Oxygenation Level-Dependent Contrast (BOLD) Breast MRI Induced by Breath- Holding (BOLD)

2018年7月30日更新者：Duke University

A Pilot Study of the Feasibility of Blood Oxygenation Level-Dependent Contrast ( BOLD) Breast MRI Induced by Breath- Holding

In this study, investigators intend to measure changes in BOLD contrast in the breast induced by breath-holding for subjects receiving radiation therapy to the breast. This study will provide the preliminary data and experience needed to successfully apply BOLD to quantify changes in oxygenation and blood flow of breast and tumor for a larger cohort of breast radiotherapy patients. The current study has the following objectives:

To determine the feasibility of BOLD contrast MRI of the breast, induced by breath-hold.
To measure the change in BOLD contrast of the breast and / or chest wall tissue for females undergoing radiotherapy

研究概览

地位

完全的

条件

乳腺癌

详细说明

11 subjects were consented to the trial. One subject voluntarily withdrew before any study procedures were performed.

研究类型

观察性的

注册 (实际的)

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

美国
- North Carolina
  - Durham、North Carolina、美国、27710
    - Duke University Medical Center

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年及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

女性

取样方法

非概率样本

研究人群

Female subjects with breast cancer

描述

Inclusion Criteria: • Post-operative patients who are undergoing planning for future whole breast radiation therapy may be included in the study

Female
Age ≥18
Negative serum pregnancy test for women of child bearing potential
Signed study-specific informed consent

Exclusion Criteria:

Unable to perform breath-holding of adequate duration.
Unable to lie prone for approximately one hour during the study procedure
Breast implants
Any condition for which a MRI procedure is contraindicated including presence of metallic material in the body, such as pacemakers, non- MRI compatible surgical clips, shrapnel, etc.
Positive serum pregnancy test
Mastectomy

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

研究衡量的是什么？

主要结果指标

结果测量	措施说明	大体时间
The change in BOLD contrast of the breasts and / or chest wall tissue will be measured by comparing breath hold sequences to normal breathing. 大体时间：During MRI approx 1 hour	Subjects will be evaluated holding their breath and during normal breathing.	During MRI approx 1 hour
Feasibility as measured by a BOLD contrast signal in at least 30% of subjects 大体时间：During MRI approx one hour	The imaging technique will be considered feasible if for any of the proposed imaging sequences, breath-holding induces a measurable (≥3× standard deviation of background) BOLD contrast signal in at least 30% of the subjects. Contrast will be measured by comparing breath hold sequences to normal breathing.	During MRI approx one hour

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

Duke University

调查人员

首席研究员：Rachel Blitzblau, MD PhD、Duke University

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

2013年9月1日

初级完成 (实际的)

2014年4月1日

研究完成 (实际的)

2014年4月1日

研究注册日期

首次提交

2013年7月9日

首先提交符合 QC 标准的