Molecular Imaging of the Hypoxic Tumor Microenvironment to Predict Response to Yttirum-90 Selective Internal Radiation Therapy in Hepatocellular Carcinoma- Pilot Study
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 2
- 主要终点
- To investigate the variability of hypoxia in HCC at baseline as quantified by BOLD MRI
研究概览
简要总结
This early phase I trial evaluates the use of hypoxia (lack of oxygen) as a measure in determining the outcome of Y90 selective internal radiation therapy in patients with liver cancer that has spread to a limited number of sites (oligometastatic). Radioembolization with Y90 is a minimally invasive procedure that combines embolization and radiation therapy to treat metastatic liver cancer. Tiny beads filled with radioactive isotope Y-90 are placed inside the blood vessel that provide blood supply to the tumor. This will block the blood flow to the tumor cells while providing a high radiation dose without harming healthy normal tissue.
详细描述
PRIMARY OBJECTIVE:
I. To investigate the variability of hypoxia in hepatocellular carcinoma (HCC) as quantified by blood oxygen level-dependent (BOLD) magnetic resonance imaging (MRI) and dynamic 18F-Fluoromisonidazole (FMISO) positron emission tomography (PET).
SECONDARY OBJECTIVES:
I. Investigate whether hypoxia, as quantified by BOLD MRI, dynamic FMISO PET, HIF-1alpha and VEGF expression, predicts HCC response to yttrium-90 (Y90) selective internal radiation therapy (SIRT).
II. Assess whether hypoxia quantification by BOLD MRI, dynamic FMISO, HIF-1alpha or VEGF expression individually or in combination more accurately predict the degree of HCC tumor response to Y90 SIRT.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >= 18 years
- •Established HCC diagnosis, unilobar or bilobar disease
- •At least 1 tumor >= 3 cm
- •Oligometastatic disease
- •Barcelona Clinic Liver Cancer (BCLC) stage A, B or C
- •Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)
- •Life expectancy > 12 weeks as determined by the Investigator
- •The effects of Y90 Radioembolization on the developing human fetus are unknown. For this reason, female of child-bearing potential (FCBP) must have a negative serum or urine pregnancy test prior to starting therapy
- •FCBP and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately
- •A female of childbearing potential (FCBP) is a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months
排除标准
- •Patients who are definite transplant candidates
- •Concurrent second malignancy outside of the liver
- •Infiltrative liver tumor
- •Previous liver-directed therapy to targeted tumors
- •BCLC stage D
- •Bilirubin > 2 mg/dL for lobar treatment and bilirubin > 3 mg/dL for segmental or bi-segmental Y90-SIRT
- •Albumin < 3 g/dL
- •Projected lung dose of > 30 Gy in a single session to the liver after prospective treatment planning
- •Body mass index (BMI) > 40
结局指标
主要结局
To investigate the variability of hypoxia in HCC at baseline as quantified by BOLD MRI
时间窗: From weeks 1-2 up to 1 year
Threshold \<1.0 R2 tumor to normal ratio (no unit) as a cutoff for hypoxia
To investigate the variability of hypoxia in HCC at baseline as quantified by immunohistochemistry
时间窗: From weeks 1-2 up to 1 year
The staining intensity will be measured and scored with four scales: no staining=0, weak staining=1, moderate staining=2, and strong staining=3. The final staining score will be obtained by stained stumor area% x positive tumor cells % x staining intensity. The tumors will be then categorized as hypoxic (scores 8 to 16) vs. non-hypoxic (scores 0 to 7) (no units).
次要结局
- Determine whether hypoxia is predictor of response in HCC treated with Y90 SIRT(From week 0 up to 1 year)
- Treatment response(From week 0 Up to 1 year)
研究者
David Brandon
Principal Investigator
Emory University