Correlation of Histopathological Findings With Radiation Exposure Levels After Y90 Transarterial Radioembolization (TARE) of Hepatic Metastases: A Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Correlation of tissue necrosis and radiation-induced cell injury levels with delivered dose at 72 hours
研究概览
简要总结
The purpose of this study is to study the way radioembolization works by collecting biopsy samples of participants' tumors after the procedure. This research may improve the way that radioembolization is performed, which could help people whose cancer has spread to the liver. The research may also provide information about how tumors respond to radioembolization.
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
- •age ≥ 18 years
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- •histologically confirmed primary adenocarcinoma of the colon or rectum
- •CLM considered unresectable or not amenable to percutaneous ablation
- •existent tissue samples from a standard of care biopsy of the target tumor within 42 days prior to treatment OR clinical indication for biopsy at the time of the treatment under the institutional guidelines for progression of disease.
- •adequate blood cell counts (WBC > 1.5 x 109/L, platelet count > 50 x 109/L)
- •adequate renal function (creatinine < 1.5 mg/dL)
- •total bilirubin level ≤ 1.5 mg/dL
- •Additional inclusion criteria for patients, undergoing 90Y radiation segmentectomy:
- •A. patients not amenable to surgery or thermal ablation
排除标准
- •Study exclusion criteria will be similar to general TARE exclusion criteria, which are as follows:
- •prior hepatic radiotherapy (The lesion / lobe being treated cannot have had prior treatment with radiotherapy - untreated lesions / lobes in the liver may be evaluated under the protocol)
- •severe cirrhosis
- •severe portal hypertension
- •uncorrectable flow to the gastrointestinal tract and/or >30 Gy (or >50 Gy in multiple sessions) radiation absorbed dose to the lungs
- •All patients with liver-dominant disease will be considered candidates for TARE even in the face of oligometastatic (up to 5 sites) extrahepatic disease, that is stable or controlled by chemotherapy.
研究组 & 干预措施
Participants with colorectal cancer liver metastases
The study population is represented by patients with colorectal cancer liver metastases that have been deemed clinically appropriate/eligible to receive Y90 TARE for the management of their liver metastases.
干预措施: Y90 TARE (Radiation)
Participants with colorectal cancer liver metastases
The study population is represented by patients with colorectal cancer liver metastases that have been deemed clinically appropriate/eligible to receive Y90 TARE for the management of their liver metastases.
干预措施: PET/CT (Diagnostic Test)
Participants with colorectal cancer liver metastases
The study population is represented by patients with colorectal cancer liver metastases that have been deemed clinically appropriate/eligible to receive Y90 TARE for the management of their liver metastases.
干预措施: PET/MRI (Diagnostic Test)
结局指标
主要结局
Correlation of tissue necrosis and radiation-induced cell injury levels with delivered dose at 72 hours
时间窗: 72 hours after treatment
Determine the feasibility of correlating tissue necrosis and radiation-induced cell injury levels with delivered dose within the target colorectal cancer liver metastases (CLM) and the uninvolved liver parenchyma.
Correlation of tissue necrosis and radiation-induced cell injury levels with delivered dose at 14-21 days
时间窗: Between 14-21 days after treatment
Determine the feasibility of correlating tissue necrosis and radiation-induced cell injury levels with delivered dose within the target colorectal cancer liver metastases (CLM) and the uninvolved liver parenchyma.
次要结局
未报告次要终点