NCT01163526终止不适用
Perfusion CT as a Predictor of Treatment Response in Patients With Hepatic Malignancies
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Predict RECIST response to treatment
研究概览
简要总结
A research study of liver perfusion (how blood flows to the liver over time). We hope to learn whether perfusion characteristics of liver masses may be predictive of response to treatment and whether liver perfusion characteristics can be used to follow response to treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •3.1.1 Patients with suspected or biopsy-proven liver masses including unresectable hepatocellular carcinoma (HCC), unresectable colon cancer metastases to the liver, and metastatic neuroendocrine tumors to the liver will be eligible for enrollment.
- •3.1.2 Patients who have undergone prior chemotherapy more than one year prior to the study are eligible for enrollment.
- •3.1.4 Patients must be 18 years or older. Patients must not be pregnant and, if of child-bearing age, must take precautions not to become pregnant.
- •3.1.5 No life expectancy restrictions.
- •3.1.6 ECOG and Karnofsky Performance Status will not be employed.
- •3.1.7 Patients with renal failure are ineligible for this study (Glomerular filtration rate (GFR) must be > 60)
- •3.1.8 Ability to understand and willingness to sign a written informed consent document.
排除标准
- •3.2.1 Patients who have undergone prior chemoembolization of hepatocellular carcinoma (HCC) are ineligible for enrollment. Patients who have undergone chemotherapy within one year prior to the study are also ineligible for enrollment.
- •3.2.2 No restrictions regarding use of other investigational agents.
- •3.2.3 Patients with severe contrast allergy are ineligible.
- •3.2.4 Patients who are pregnant or are trying to become pregnant are excluded from this study.
- •3.2.5 Patients who are cancer survivors or Human Immunodeficiency Virus (HIV)-positive will not be excluded.
结局指标
主要结局
Predict RECIST response to treatment
时间窗: at 3 months from CT perfusion parameters before and after treatment
次要结局
- Predict disease progression(1 yr)
- Characterize CT perfusion longitudinally in both responders and nonresponders(1 yr)
研究者
研究点 (1)
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