A Pilot Study of the Feasibility of Blood Oxygenation Level-Dependent Contrast ( BOLD) Breast MRI Induced by Breath- Holding
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- The change in BOLD contrast of the breasts and / or chest wall tissue will be measured by comparing breath hold sequences to normal breathing.
研究概览
简要总结
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
详细描述
11 subjects were consented to the trial. One subject voluntarily withdrew before any study procedures were performed.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- 否
入选标准
- •Post-operative patients who are undergoing planning for future whole breast radiation therapy may be included in the study
- •Negative serum pregnancy test for women of child bearing potential
- •Signed study-specific informed consent
排除标准
- •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
结局指标
主要结局
The change in BOLD contrast of the breasts and / or chest wall tissue will be measured by comparing breath hold sequences to normal breathing.
时间窗: During MRI approx 1 hour
Subjects will be evaluated holding their breath and during normal breathing.
Feasibility as measured by a BOLD contrast signal in at least 30% of subjects
时间窗: 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.
次要结局
未报告次要终点