Liver Volume Variation Effect on SBRT Planning and Delivery for Upper Abdominal Malignancies

Not Applicable

Recruiting

• Conditions: Upper Abdominal Malignancies

• Registration Number: NCT06355895
• Lead Sponsor: University of Pittsburgh

Brief Summary

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.

Study Timeline

• Study First Submitted: 2024-04-02
• Study First Submitted QC: 2024-04-02
• Study First Posted: 2024-04-10
• Study Start: 2024-05-16
• Status Verified: 2025-07
• Last Update Submitted: 2025-08-06
• Last Update Posted: 2025-08-07
• Primary Completion: 2026-03-31
• Study Completion: 2026-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 17

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Diurnal Difference in Liver Volumes	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.

Secondary Outcome Measures

Name	Time	Method
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 V15 Gy (measured by Stereotactic Body Radiation Therapy (SBRT) planning software) after standardized high-carb meal (intervention).
Percentage diurnal difference in liver mean dose at V5 Gy	At baseline and at 1 hour post intervention	Percentage diurnal difference in liver mean dose at V5 Gy (measured by Stereotactic Body Radiation Therapy (SBRT) planning software) after standardized high-carb meal (intervention).
Difference in liver dose at V15 Gy	At baseline and at 1 hour post intervention	Percentage difference in liver mean dose at V15 Gy (measured by Stereotactic Body Radiation Therapy (SBRT) planning software) after standardized high-carb meal (intervention).
Difference in total liver volume	At baseline and at 1 hour post intervention	Percentage difference in total liver volume (measured by Stereotactic Body Radiation Therapy (SBRT) planning software) after standardized high-carb meal (intervention).
Difference in liver mean dose at V15 Gy	At baseline and at 1 hour post intervention	Percentage difference in liver mean dose, V5 Gy (measured by Stereotactic Body Radiation Therapy (SBRT) planning software) after standardized high-carb meal (intervention).

Trial Locations

Locations (1)

UPMC Hillman Cancer Center; 🇺🇸 Pittsburgh, Pennsylvania, United States