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

NCT ID: NCT06355895

Last Updated: 2025-08-07

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-16
• Study Completion Date: 2026-03-31

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.

Conditions

Upper Abdominal Malignancies

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

High Carbohydrate Diet

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.

Group Type: EXPERIMENTAL

Standardized high-carbohydrate meal

Intervention Type: DIETARY_SUPPLEMENT

8 ounces of Ensure® nutritional protein shake or a similar meal

Interventions

Standardized high-carbohydrate meal

8 ounces of Ensure® nutritional protein shake or a similar meal

Intervention Type: DIETARY_SUPPLEMENT

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

American College of Radiation Oncology

UNKNOWN

Sponsor Role: collaborator

University of Pittsburgh

OTHER

Sponsor Role: lead

Responsible Party

Susannah Ellsworth

Clinical Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Susannah Ellsworth, MD

Role: PRINCIPAL_INVESTIGATOR

UPMC Hillman Cancer Center

Locations

UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Samantha Demko, BSN

Role: CONTACT

albesl@upmc.edu

412-623-1400

Brieanna Marino, MS

Role: CONTACT

rowlesbm@upmc.edu

412-647-8258

Facility Contacts

Samantha Demko

Role: primary

Brieanna Marino

Role: backup

Other Identifiers

HCC 23-104

Identifier Type: -

Identifier Source: org_study_id