Characterizing Tumor Hypoxia With BOLD-MRI to Predict Y-90 Treatment Response (BOLDMRI)
Characterization of the Hypoxic Tumor Microenvironment With Blood Oxygen Level-Dependent Magnetic Resonance Imaging for the Prediction of Hepatocellular Carcinoma Response to Yttrium-90 Selective Internal Radiation Therapy
The purpose of this study is to find out whether a special type of magnetic resonance imaging ( MRI), called blood oxygen level-dependent (BOLD) MRI, can help measure how much oxygen is present in liver tumors. Tumors with low oxygen levels are described as being hypoxic.
Yttrium-90 (Y-90) is a type of radioactive material used to treat liver tumors, including hepatocellular carcinoma (HCC), a type of liver cancer. Y-90 is a form of radiation treatment delivered directly to liver tumors through tiny beads carried by blood vessels. These beads release radiation that damages and kills cancer cells while helping limit radiation exposure to surrounding healthy tissue. This treatment is also called Y-90 radioembolization or selective internal radiation therapy (SIRT).
研究概览
详细说明
The study will include 12 patients with liver tumors confirmed by biopsy to be hepatocellular carcinoma (HCC), a type of liver cancer, who are scheduled to receive Y-90 selective internal radiation therapy (SIRT), a treatment that delivers radiation directly to the tumor through blood vessels. Before treatment, participants will undergo a research MRI scan. A sample of their previously biopsied tumor tissue will also be examined in the laboratory to measure signs of low oxygen levels. The researchers will compare the MRI findings with the tissue results to determine whether BOLD MRI can reliably assess oxygen levels in liver tumors and may help predict how well the tumors respond to Y-90 treatment.
Standard-of-care Dynamic Contrast-Enhanced Magnetic Resonance Imaging (DCE MRI) will be performed separately according to routine clinical practice before and after the Y90-SIRT procedure. BOLD MRI will be performed on a separate day after the pre-SIRT DCE MRI.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Markeela Lipscomb
- 电话号码：919-972-7440
- 邮箱：markeela_lipscomb@med.unc.edu
研究联系人备份
- 姓名：Kaila Brustkern
- 电话号码：984-974-3226
- 邮箱：kaila_brustkern@med.unc.edu
学习地点
-
-
North Carolina
-
Chapel Hill、North Carolina、美国、27599
- UNC Lineberger Comprehensive Cancer Center
-
接触：
- Markeela Lipscomb
- 电话号码：919-972-7440
- 邮箱：markeela_lipscomb@med.unc.edu
-
接触：
- Kaila Brustkern
- 电话号码：984-974-3226
- 邮箱：kaila_brustkern@med.unc.edu
-
首席研究员：
- Alexander Villalobos, MD
-
首席研究员：
- Bryan Harris, MD
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-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
Subjects must meet all the inclusion criteria to participate in this study.
- Adults ≥ 18 years
- Liver mass(es) suspected of being HCC by imaging and are amenable to undergo percutaneous liver mass biopsy to confirm the HCC diagnosis, as determined by the institutional multidisciplinary tumor board.
- At least 1 tumor ≥ 2 cm and deemed to benefit from Y90 radioembolization by the institutional multidisciplinary tumor board.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤2 (Karnofsky Performance Status (KPS) ≥60%)
- Life expectancy ≥6 months, as determined by the investigator.
Exclusion Criteria:
All subjects meeting any of the exclusion criteria at baseline will be excluded from study participation.
- Definite liver transplant candidate
- Concurrent secondary malignancy
- Distant metastasis
学习计划
研究是如何设计的？
设计细节
- 主要用途：诊断
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Hepatocellular carcinoma
Patients with hepatocellular carcinoma (HCC) who are scheduled to receive Y-90 selective internal radiation therapy (SIRT), |
BOLD MRI will include 2D and 3D multi-echo gradient-echo sequences covering the liver, using body phased-array coils and breath-hold techniques. Imaging parameters may be adjusted as needed to optimize tumor visualization while maintaining data quality. |
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 number of successful novel blood oxygen level dependent (BOLD) magnetic resonance imaging (MRI)
大体时间：Baseline
|
The number of successful novel blood oxygen level dependent (BOLD) magnetic resonance imaging (MRI) method for evaluating the level of tumor tissue hypoxia in patients with liver tumors. |
Baseline
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Hepatocellular carcinoma (HCC) hypoxia classification based on blood oxygen level dependent (BOLD) magnetic resonance imaging (MRI)
大体时间：Baseline
|
Calculation of sensitivity, specificity, positive predictive value and negative predictive value of blood oxygen level dependent (BOLD) magnetic resonance imaging (MRI) based hepatocellular carcinoma (HCC) hypoxia classification. |
Baseline
|
合作者和调查者
调查人员
- 首席研究员：Alexander Villalobos, MD、UNC Lineberger Comprehensive Cancer Center
- 首席研究员：Bryan Harris, MD、UNC Lineberger Comprehensive Cancer Center
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
关键字
其他相关的 MeSH 术语
其他研究编号
- LCCC2446
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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