Radioembolization for HCC Patients With Personalized Yttrium-90 Dosimetry for Curative Intent (RAPY90D)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- Tumor objective response rate (ORR)
研究概览
简要总结
This trial aims to improve hepatocellular carcinoma (HCC) tumor responses in patients undergoing Y90 radioembolization by using personalized dosimetry as part of treatment planning. Using standard calculations for Y90 doses may not be specific enough for individual patients given that there can be differences in how tumor cells and liver cells respond to radiation. Personalized dose plans may help improve treatment and outcomes in liver cancer.
详细描述
PRIMARY OBJECTIVES:
I. To achieve tumor objective response rates of 75% using voxel based dosimetry when the mean dose (Dmean) to tumor is targeted to be greater than 200 Gray (Gy).
SECONDARY OBJECTIVES:
I. Correlate changes in liver function and Common Terminology Criteria for Adverse Events (CTCAE) incidence to the mean absorbed dose to normal liver.
II. Prospectively validate the accuracy of our published tumor dose response prediction based on the yttrium Y 90 glass microspheres (yttrium-90 [Y90]) tumor dose volume histograms (DVHs).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •1. Patients over 18 years of age, of any race or sex, who have unresectable hepatocellular carcinoma of the liver, and who are able or have a fully able legal guardian to give informed consent, will be eligible. Patients must have an ECOG Performance Status score of \/=3 months, and must be non-pregnant with an acceptable contraception in premenopausal women. Patients must be \>4 weeks since prior radiation or prior surgery and at least one month post chemotherapy.
- •2. At least one lesion \>/= 3.0 cm in shortest dimension
- •3. AST or ALT \<5 times ULN
- •4. Bilirubin \
排除标准
- •Contraindications to angiography and selective visceral catheterization
- •Evidence of potential delivery of greater than 16.5 mCi (30 Gy absorbed dose) to the lungs with a single injection, or greater than 50 Gy for multiple injections
- •Evidence of any detectable Tc-99m MAA flow to the stomach or duodenum, after application of established angiographic techniques to stop or mitigate such flow (eg, placing catheter distal to gastric vessels)
- •Significant extrahepatic disease representing an imminent life-threatening outcome
- •Severe liver dysfunction or pulmonary insufficiency
- •Active uncontrolled infection
- •Significant underlying medical or psychiatric illness
- •Pre-existing diarrhea/illness, co-morbid disease or condition that would preclude safe delivery of TheraSphere® treatment and place the patient at undue risk
- •Infiltrative tumors
研究组 & 干预措施
Treatment (personalized radioembolization, SPECT/CT HIDA)
Patients undergo yttrium-90 microsphere radioembolization with yttrium Y 90 glass microspheres using personalized dose measurements. Patients also undergo SPECT/CT HIDA scan before radioembolization and 2-4 months after radioembolization.
干预措施: Computed Tomography (Procedure)
Treatment (personalized radioembolization, SPECT/CT HIDA)
Patients undergo yttrium-90 microsphere radioembolization with yttrium Y 90 glass microspheres using personalized dose measurements. Patients also undergo SPECT/CT HIDA scan before radioembolization and 2-4 months after radioembolization.
干预措施: Hepatobiliary Iminodiacetic Acid Scan (Other)
Treatment (personalized radioembolization, SPECT/CT HIDA)
Patients undergo yttrium-90 microsphere radioembolization with yttrium Y 90 glass microspheres using personalized dose measurements. Patients also undergo SPECT/CT HIDA scan before radioembolization and 2-4 months after radioembolization.
干预措施: Single Photon Emission Computed Tomography (Procedure)
Treatment (personalized radioembolization, SPECT/CT HIDA)
Patients undergo yttrium-90 microsphere radioembolization with yttrium Y 90 glass microspheres using personalized dose measurements. Patients also undergo SPECT/CT HIDA scan before radioembolization and 2-4 months after radioembolization.
干预措施: Yttrium-90 Microsphere Radioembolization (Procedure)
Treatment (personalized radioembolization, SPECT/CT HIDA)
Patients undergo yttrium-90 microsphere radioembolization with yttrium Y 90 glass microspheres using personalized dose measurements. Patients also undergo SPECT/CT HIDA scan before radioembolization and 2-4 months after radioembolization.
干预措施: Yttrium Y 90 Glass Microspheres (Radiation)
结局指标
主要结局
Tumor objective response rate (ORR)
时间窗: Up to 6 months
Assessed with modified Response Evaluation Criteria in Solid Tumors (mRECIST) criteria. The ORR of treated tumors will be determined. Will perform a cluster bootstrap in which patients (not tumors) are sampled with replacement. Will construct a 95% confidence interval using the 2.5% and 97.5% quantiles of the bootstrap sampling distribution.
次要结局
- Development of tumor dose response model prediction based on MAA dose maps(Up to 6 months)
- Prediction of tumor doses macroaggregated albumin (MAA) scan with actual doses delivered (Y90 scan)(Up to 6 months)
- Accuracy of published tumor dose response prediction based on the yttrium-90 (Y90) tumor dose volume histograms(Up to 6 months)
- Changes in liver function(Up to 6 months)
- Changes in Common Terminology Criteria for Adverse Events (CTCAE) incidence(Up to 6 months)
- Development of a model correlating normal liver radiation dose to liver function using single-photon emission computed tomography computed tomography hepatobiliary iminodiacetic acid (SPECT CT HIDA) imaging(Up to 6 months)