Liver Volume Variation Effect on SBRT Planning and Delivery for Upper Abdominal Malignancies
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Standardized high-carbohydrate meal.
- Who it may be relevant to
- Registry conditions: Upper Abdominal Malignancies. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
The Effect of Liver Volume Variation on Stereotactic Body Radiation Therapy (SBRT) Planning and Delivery for Upper Abdominal Malignancies
Overview
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.
Detailed description
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.
Interventions
- Dietary supplement Standardized high-carbohydrate meal
8 ounces of Ensure® nutritional protein shake or a similar meal
Primary outcome measures
- Diurnal Difference in Liver Volumes [Time frame: At baseline and at 4 hours post intervention]
Secondary outcome measures (5)
- Difference in total liver volume [Time frame: At baseline and at 1 hour post intervention]
- Percentage diurnal difference in liver mean dose at V5 Gy [Time frame: At baseline and at 1 hour post intervention]
- Percentage diurnal difference in liver mean dose at V15Gy [Time frame: At baseline and at 1 hour post intervention]
- Difference in liver mean dose at V15 Gy [Time frame: At baseline and at 1 hour post intervention]
- Difference in liver dose at V15 Gy [Time frame: At baseline and at 1 hour post intervention]
Eligibility criteria
Inclusion criteria
- Have primary upper abdominal (pancreatic, bile duct, liver) cancer or upper abdominal metastases (liver, adrenal, upper abdominal lymph nodes) planned to undergo SBRT.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Health services research
Study locations
United States · 1 center
- UPMC Hillman Cancer Center — Pittsburgh
Identifiers
NCT: NCT06355895 · HCC 23-104