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

NCT06355895 | Recruiting DMC

• 1 other identifier: HCC 23-104
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Upper Abdominal Malignancies

Keywords

Stereotactic Body Radiation Therapy (SBRT); Four-Dimensional Computed Tomography

Outcome Measures

Primary Outcomes (1)

• Diurnal Difference in Liver Volumes

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

  At baseline and at 4 hours post intervention

Secondary Outcomes (5)

• Difference in total liver volume

  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

• Percentage diurnal difference in liver mean dose at V15Gy

  At baseline and at 1 hour post intervention

• Difference in liver mean dose at V15 Gy

  At baseline and at 1 hour post intervention

• Difference in liver dose at V15 Gy

  At baseline and at 1 hour post intervention

Study Arms (1)

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.

Dietary Supplement: Standardized high-carbohydrate meal

Interventions

Standardized high-carbohydrate meal DIETARY_SUPPLEMENT

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

High Carbohydrate Diet

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Pittsburgh: lead
• American College of Radiation Oncology: collaborator

Study Sites (1)

UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, 15232, United States

RECRUITING

Study Officials

• Susannah Ellsworth, MD

  UPMC Hillman Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Samantha Demko, BSN

CONTACT

412-623-1400; albesl@upmc.edu

Brieanna Marino, MS

CONTACT

412-647-8258; rowlesbm@upmc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor

Study Record Dates

• First Submitted: April 2, 2024
• First Posted: April 10, 2024
• Study Start: May 16, 2024
• Primary Completion (Estimated): March 31, 2028
• Study Completion (Estimated): March 31, 2028
• Last Updated: June 11, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)