This clinical trial studies what effects a high-carbohydrate (carb) meal has on liver size and whether the changes in liver size can affect the dose of radiation given during stereotactic body radiation therapy (SBRT) for upper abdominal cancer. Before a patient undergoes SBRT, the treatment is planned, which includes taking images (scans) of various organs using a method called computed tomography (CT). This is to make sure that only the cancer is treated with radiation, and that healthy tissue around the cancer and organs that are very sensitive to radiation and could be damaged are not affected. Some organs, like the liver, can change in size after eating, and this must be considered. This study seeks to find out how much the size of the liver changes on the CT scan a few hours after a patient has had a high-carb meal and to see how these changes in liver size can affect the dose of radiation used, because the dose is given according to the liver size. This may improve SBRT planning and delivery for upper abdominal cancer.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT06355895.
Locations matching your search criteria
United States
Pennsylvania
Pittsburgh
University of Pittsburgh Cancer Institute (UPCI)Status: Active
Contact: Susannah (Yovino) G. Ellsworth
Phone: 412-623-6720
PRIMARY OBJECTIVE:
I. To assess diurnal changes in liver volume between two simulation CT scans, the first acquired in the morning following an overnight fast and the second acquired four hours after the first scan following a standardized high-carb meal.
SECONDARY OBJECTIVES:
I. To assess changes in liver volume immediately following a standard high-carb meal.
II. To assess the extent to which liver volume variations affect dose-volume distribution in the liver, including mean liver dose and liver volume (in cubic centimeter [cc]) receiving ≥ 5 gray (Gy) and ≥ 15 Gy.
OUTLINE:
Patients complete an overnight fast of at least 8 hours and then undergo CT with intravenous (IV) contrast early the following morning, at approximately 8 ante meridiem (am). Immediately following CT scan, patients consume a standardized high-carb meal over 15 minutes. Patients then undergo CT within 1 hour of high-carb meal and again at least 4 hours, but no more than 5 hours, after high-carb meal.
Trial PhaseNo phase specified
Trial Typebasic science
Lead OrganizationUniversity of Pittsburgh Cancer Institute (UPCI)
Principal InvestigatorSusannah (Yovino) G. Ellsworth
