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A Study of Changes in Hepatic Function During Radiation Therapy Using Hepatobiliary Single Photon Emission Tomography (SPECT)

This study has been completed.
Information provided by (Responsible Party):
University of Michigan Cancer Center Identifier:
First received: September 23, 2011
Last updated: May 14, 2015
Last verified: May 2015
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.

Condition Intervention
Hepatocellular Carcinoma
Radiation: Liver Irradiation

Study Type: Observational
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

Further study details as provided by University of Michigan Cancer Center:

Primary Outcome Measures:
  • Changes in hepatobiliary single photon emission tomography (SPECT) after radiation therapy [ Time Frame: 6 months ]
    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.

Secondary Outcome Measures:
  • measuring values between regional radiation dose and local hepatic function as measured by hepatobiliary SPECT, in normal liver parenchyma [ Time Frame: 6 months ]
    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.

Enrollment: 23
Study Start Date: August 2008
Study Completion Date: May 2014
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Liver Irradiation
patients already scheduled to undergo liver irradiation
Radiation: Liver Irradiation
Patients already scheduled to undergo radiation treatment

Detailed Description:
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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
cancer patients undergoing radiation of the Liver

Inclusion Criteria:

  • cancer patients undergoing radiation of the Liver
  • women and men who agree to avoid pregnancy
  • life expectancy of at least 6 months

Exclusion Criteria:

  • pregnant women
  • breatsfeeding women
  • prisoners
  Contacts and Locations
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Please refer to this study by its identifier: NCT01519232

United States, Michigan
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States, 48109-5010
Sponsors and Collaborators
University of Michigan Cancer Center
Principal Investigator: Mary Feng, MD University of Michigan Cancer Center
  More Information

Responsible Party: University of Michigan Cancer Center Identifier: NCT01519232     History of Changes
Other Study ID Numbers: UMCC 2007-110
HUM00015656 ( Other Identifier: University of Michigan Medical IRB )
Study First Received: September 23, 2011
Last Updated: May 14, 2015

Keywords provided by University of Michigan Cancer Center:
hepatocellular carcinoma

Additional relevant MeSH terms:
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases processed this record on May 24, 2017