A Study of Changes in Hepatic Function During Radiation Therapy Using Hepatobiliary Single Photon Emission Tomography (SPECT)
Radiation-induced liver disease (RILD) is a syndrome characterized by the development of anicteric ascites approximately 2 weeks to 4 months after hepatic irradiation. Previous studies have shown that both the volume of liver irradiated and the dose of radiation delivered are prominent factors for development of RILD. While use of a population-based normal tissue complication probability model allows investigators to limit the risk of RILD to a clinically acceptable level, a test that permits investigators to determine an individual's risk of RILD during the course of treatment may allow for individualized treatment modifications, either to prevent toxicity or increase efficacy.
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||A Pilot Study of Changes in Hepatic Function During Radiation Therapy Using Hepatobiliary SPECT|
- Changes in hepatobiliary single photon emission tomography (SPECT) after radiation therapy [ Time Frame: 6 months ] [ Designated as safety issue: No ]Changes in SPECT, which reflect hepatocyte function, will be correlated with specific regions of radiation dose to determine a relationship between dose and radiation-induced damage.
- measuring values between regional radiation dose and local hepatic function as measured by hepatobiliary SPECT, in normal liver parenchyma [ Time Frame: 6 months ] [ Designated as safety issue: No ]dynamic hepatobiliary single photon emission tomography (SPECT) values will assess changes in hepatocyte function in patients with intrahepatic malignancies receiving radiation therapy. Perhaps a relationship between SPECT and dosage can be determined.
|Study Start Date:||August 2008|
|Study Completion Date:||May 2014|
|Primary Completion Date:||June 2012 (Final data collection date for primary outcome measure)|
patients already scheduled to undergo liver irradiation
Radiation: Liver Irradiation
Patients already scheduled to undergo radiation treatment
Early, but subclinical physiologic changes in the liver may be associated with the future development of RILD. There are currently limited data on how a local change in hepatic function associates with regional radiation dose, and how the change of hepatic function during and after radiation therapy (RT) associates with RILD. In the present study, a radiological methodology that is minimally invasive will be used to measure volumetric hepatic functions in patients with intrahepatic malignancies before, during, and after a course of fractioned radiation therapy.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01519232
|United States, Michigan|
|University of Michigan Comprehensive Cancer Center|
|Ann Arbor, Michigan, United States, 48109-5010|
|Principal Investigator:||Mary Feng, MD||University of Michigan Cancer Center|