Intrinsic Dosimetry for Radioembolization Utilizing PET-CT Imaging Data: A Prospective Registry Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Radiation dose to 70% of the tumor volume, evaluated using PET-CT
研究概览
简要总结
This clinical trial studies positron emission tomography (PET)-computed tomography (CT) in determining the radiation dose delivered with radioactive spheres to patients with liver metastasis or primary liver or biliary cancer. Comparing results of diagnostic procedures dose before and after delivery of radioactive spheres to the liver may help determine radioembolization dose and plan the best treatment for liver metastasis or primary liver or biliary cancer.
详细描述
PRIMARY OBJECTIVES:
I. To determine the relationship between radiation dose to 70% of the tumor volume as determined by post-treatment positron emission tomography (PET)-computed tomography (CT) and local control at 6 months.
SECONDARY OBJECTIVES:
I. To evaluate the ability of PET-CT to reproducibly determine dose to tumor, normal liver, and other surrounding organs.
II. To determine the stability of microsphere location by examining the changes in dose in a subset of patients with PET-CT scans performed on day 0 and day 1.
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
- •Patients must have liver-dominant or liver-only metastatic disease from any primary histology; patients with primary hepatocellular or biliary cancer are also eligible
- •Patients must be clinical candidates for radioembolization with either SIR-spheres or TheraSphere due to metastatic or primary malignancies of the liver
- •Women of child bearing potential must have a negative serum pregnancy test no more than 72 hours prior to registration
- •Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1 or 2
- •Ability to understand and willingness to sign a written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of medical information
- •Complete blood count (CBC) and chemistry panel (CMP) no greater than 4 weeks prior to visit 1
- •Diagnostic imaging of the abdomen utilizing either CT with contrast, magnetic resonance imaging (MRI), or PET/CT no greater than 4 weeks prior to visit 1
排除标准
- •Patients not undergoing radioembolization to the liver
- •Women of childbearing potential (WOCBP) and men who refuse to comply with appropriate contraception
- •Women who are either pregnant or breast feeding
研究组 & 干预措施
Diagnostic: PET scan - CT scan
Patients undergo PET-CT scan before and after standard radioembolization on day 0. A subset of patients undergo PET-CT scan on day 1, 24 hours after the day 0 post-treatment PET-CT.
干预措施: PET scan (Procedure)
Diagnostic: PET scan - CT scan
Patients undergo PET-CT scan before and after standard radioembolization on day 0. A subset of patients undergo PET-CT scan on day 1, 24 hours after the day 0 post-treatment PET-CT.
干预措施: CT Scan (Procedure)
Diagnostic: PET scan - CT scan
Patients undergo PET-CT scan before and after standard radioembolization on day 0. A subset of patients undergo PET-CT scan on day 1, 24 hours after the day 0 post-treatment PET-CT.
干预措施: hepatic artery embolization (Procedure)
结局指标
主要结局
Radiation dose to 70% of the tumor volume, evaluated using PET-CT
时间窗: Up to day 1
Standard summary measures such as means, medians, ranges, and standard deviations will be used to characterize the dosages received by tumor and other tissue. The relationship between radiation dose and local control will be determined using regression models with Generalized Estimating Equations (GEE) to account for within-patient correlation. Logistic regression will be used to adjust for potentially confounding factors such as tumor volume, primary histology, and SIR-Spheres versus Therasphere intervention.
Local control
时间窗: At 6 months
The relationship between radiation dose and local control will be determined using regression models with GEE to account for within-patient correlation.
次要结局
- Distribution predicted by T-99m labeled MAA(Baseline)
- Distribution of activity measured by PET-CT(Up to day 1)
- Change in dose measured by PET-CT scan(Day 0 to day 1)
- Ability of PET-CT to reproducibly determine dose to tumor, normal liver, and other surrounding organs(Up to day 1)
- Side effects of radiation dose to healthy tissue such as fatigue, nausea, pain, and elevated liver function tests(Up to 5 years)