跳至主要内容
临床试验/NCT06355895
NCT06355895招募中不适用

The Effect of Liver Volume Variation on Stereotactic Body Radiation Therapy (SBRT) Planning and Delivery for Upper Abdominal Malignancies

University of Pittsburgh2 个研究点 分布在 1 个国家目标入组 17 人开始时间: 2024年5月16日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
17
试验地点
2
主要终点
Diurnal Difference in Liver Volumes

研究概览

简要总结

Standard planning constraints for liver SBRT incorporate strict dose-volume limits for normal liver parenchyma to minimize the risk of radiation-induced liver disease. The presence of diurnal and fasting/fed variations in liver volume therefore carry substantial potential for introducing errors into estimates of dose-volume distribution within normal liver tissue, as well as affecting day-to-day setup fidelity and organ alignment for treatment. This prospective study will examine how diurnal and fast-fed variations in liver volume affect treatment planning for abdominal SBRT.

详细描述

Stereotactic body radiotherapy (SBRT) is an integral tool in the management of thoracic and upper abdominal malignancies. SBRT delivers ablative radiation doses in a limited number of fractions (thereby reducing interruptions in systemic therapy) with emerging evidence for feasibility and local control benefit. Effective SBRT delivery requires high-precision target localization that accounts for positional variations in both the target and nearby organs at risk (OAR). An absolute requirement for SBRT is accurate target localization and motion management, particularly when treating targets in the chest and abdomen, which are subject to respiratory motion as well as changes in configuration due to deformation of hollow viscera. To ensure adequate targeting, various technical solutions are available, including motion management approaches such as four-dimensional computed tomography (4D-CT), abdominal compression, respiratory gating, and breath hold, as well as daily image-guided radiotherapy (IGRT) techniques such as cone beam computed tomography (CBCT), which facilitate precise daily target verification and minimization of the planning target volumes (PTVs). While the effects of respiratory motion on patient positioning during upper abdominal SBRT are relatively well understood, little is known about the effect of liver volume changes on radiotherapy (RT) dose delivery, despite the potential for morphological variations in the liver to affect patient setup and radiation dose distribution in real time. The liver is a dynamic organ with various functions including glycogen storage, carbohydrate (carb)/lipid/protein metabolism, bile secretion, synthesis of plasma proteins, and metabolism of various substances including steroid hormones and ingested toxins. Liver function is affected by fasting and feeding cycles, with an intrinsic circadian rhythm first observed in animal studies. This trial proposes to affect liver volume to ultimately and positively affect treatment planning for abdominal SBRT.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Health Services Research
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

入选标准

  • Have primary upper abdominal (pancreatic, bile duct, liver) cancer or upper abdominal metastases (liver, adrenal, upper abdominal lymph nodes) planned to undergo SBRT.

排除标准

  • Had prior Radiation Therapy to the liver
  • Contraindication to receipt of iodinated IV contrast for CT (such as renal insufficiency or allergy that cannot be overcome by premedication)
  • Pregnancy/lactation OR woman of childbearing potential who is unable or unwilling to use adequate contraception during Radiation Therapy.
  • Inability to fast.

研究组 & 干预措施

High Carbohydrate Diet

Experimental
  1. First scan: after an overnight fast of at least 8 hours using standard radiation oncology CT scan with contrast for treatment planning.
  2. Standardized high-carb meal such as 8 ounces of Ensure® nutritional protein shake or a similar meal, immediately following first scan and consumed within 15 minutes.
  3. Second scan: within 1 hour of ingestion of the high-carb meal using similar settings to those used in the first scan except for contrast use.
  4. Third CT scan at least 4 hours (but no more than 5 hours) after ingestion of high-carb diet on the same day utilizing same set up used in first scan with exception for the use of contrast.

干预措施: Standardized high-carbohydrate meal (Dietary Supplement)

结局指标

主要结局

Diurnal Difference in Liver Volumes

时间窗: At baseline and at 4 hours post intervention

Percentage diurnal difference in total liver volumes (change in liver volume), as measured by Stereotactic Body Radiation Therapy (SBRT) planning software.

次要结局

  • Percentage diurnal difference in liver mean dose at V15Gy(At baseline and at 1 hour post intervention)
  • Percentage diurnal difference in liver mean dose at V5 Gy(At baseline and at 1 hour post intervention)
  • Difference in total liver volume(At baseline and at 1 hour post intervention)
  • Difference in liver dose at V15 Gy(At baseline and at 1 hour post intervention)
  • Difference in liver mean dose at V15 Gy(At baseline and at 1 hour post intervention)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Susannah Ellsworth

Clinical Associate Professor

University of Pittsburgh

研究点 (2)

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