Recruiting

Observational Study

Sponsor:

University of Pittsburgh

Code:

NCT06355895

Conditions

Upper Abdominal Malignancies

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Standardized high-carbohydrate meal

Study Details

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

Study ID

NCT06355895

Start date

May 16, 2024

Status verified date

Jun, 2026

Completion date

Mar 31, 2028

Anticipated

Primary completion date

Mar 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

17 participants

Anticipated

Intervention Model

Single group

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

experimental: 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.

Interventions

Standardized high-carbohydrate meal

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

Primary outcome measure

  • Diurnal Difference in Liver Volumes [ Time Frame: At baseline and at 4 hours post intervention ]

Central Contacts and Locations

Central contacts

Samantha Demko, BSN

412-623-1400albesl@upmc.edu

Brieanna Marino, MS

412-647-8258rowlesbm@upmc.edu

Locations

UPMC Hillman Cancer Center

Recruiting

Pittsburgh, Pennsylvania, United States, 15232

Principal Investigator:

Susannah Ellsworth, MD

More Information

Sponsor

University of Pittsburgh

Last update posted

Jun 11, 2026

Last verified

Jun, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Pittsburgh on 2026-06-11.