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

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

NCT ID: NCT06355895

Condition: Upper Abdominal Malignancies

Conditions: Official terms:
Neoplasms

Conditions: Keywords:
Stereotactic Body Radiation Therapy (SBRT)
Four-Dimensional Computed Tomography

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Health Services Research

Masking: None (Open Label)

Intervention:

Intervention type: Dietary Supplement
Intervention name: Standardized high-carbohydrate meal
Description: 8 ounces of Ensure® nutritional protein shake or a similar meal
Arm group label: High Carbohydrate Diet

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.

Criteria for 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.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: UPMC Hillman Cancer Center

Address:
City: Pittsburgh
Zip: 15232
Country: United States

Status: Recruiting

Contact:
Last name: Samantha Demko

Contact backup:
Last name: Brieanna Marino

Investigator:
Last name: Susannah Ellsworth, MD
Email: Principal Investigator

Start date: May 16, 2024

Completion date: June 2025

Lead sponsor:
Agency: University of Pittsburgh
Agency class: Other

Collaborator:
Agency: American College of Radiation Oncology
Agency class: Other

Source: University of Pittsburgh

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06355895