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临床试验/NCT07033364
NCT07033364招募中不适用

Changes in Functional Liver Tissue After Liver Metastasis Irradiation: Pilot Study of Functional Imaging Before and After Stereotactic Body Radiotherapy

The Netherlands Cancer Institute1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2025年7月21日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
15
试验地点
1
主要终点
Dose-effect relationship between radiation dose and liver function by comparing the change in liver function before and after SBRT

研究概览

简要总结

In this study, the investigators aim to determine the dose-effect relationship between radiation dose and liver function by performing a hepatobiliary scintigraphy (HEBIS) before and after stereotactic body radiotherapy (SBRT) for patients with liver metastases. HEBIS is a nuclear imaging technique to quantitatively assess liver function. It better predicts the risk of postsurgical liver failure compared to volumetry alone. To prevent liver failure after SBRT, current clinical dose constraints require that ≥ 700 ml of normal liver should receive less than 15 Gy in 3 fractions. The exact local dose-effect relation is however unknown. Doses below 15 Gy are still damaging, while liver tissue receiving doses above 15 Gy will retain some function. By associating the 3D radiation dose distribution with the HEBIS scan, the investigators can evaluate the impact of radiation dose on liver function for different dose levels in liver (sub)volumes. This analysis will refine existing dose-effect relationships, enabling more tailored treatment of liver metastases in the future. Ten to fifteen patients will be included to assess functional liver imaging using HEBIS before their treatment and 3 to 4 months after their 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

入选标准

  • Patient treated for a liver metastasis with SBRT with treatment prescription of 3 x 20 Gy
  • Able to provide informed consent prior to any study specific procedure

排除标准

  • Pregnancy
  • Prior radiation therapy of the liver
  • Lactation, unable to substitute for 24 hours
  • Inability to cooperate with the scan process: inability to lie relatively still and in supine for 30-60 minutes or patient body habitus above scanner dimensions
  • Exclusion criteria for HEBIS scan:
  • GFR < 30 ml/min/1.73m2
  • < 2 weeks after antiviral eradication therapy for hepatitis C
  • Bilirubine > 30 µmol/l
  • Relative contra-indications (possibly affecting liver function): opiates, barbiturates, somatostatine, colestyramine, rifampicine, atropine

结局指标

主要结局

Dose-effect relationship between radiation dose and liver function by comparing the change in liver function before and after SBRT

时间窗: This is measured at baseline, before treatment, and after 3-4 months after treatment.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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