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

University of Michigan Rogel Cancer Center logo

University of Michigan Rogel Cancer Center

Status

Completed

Conditions

Hepatocellular Carcinoma

Treatments

Radiation: Liver Irradiation

Study type

Observational

Funder types

Other

Identifiers

NCT01519232
UMCC 2007-110
HUM00015656 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

23 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

23 participants in 1 patient group

Liver Irradiation
Description:
patients already scheduled to undergo liver irradiation
Treatment:
Radiation: Liver Irradiation

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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