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A Pilot Study of Changes in Hepatic Function During Radiation Therapy Using Hepatobiliary SPECT


N/A
18 Years
N/A
Open (Enrolling)
Both
Hepatocellular Carcinoma

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Trial Information

A Pilot Study of Changes in Hepatic Function During Radiation Therapy Using Hepatobiliary SPECT


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.


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

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

Changes in hepatobiliary single photon emission tomography (SPECT) after radiation therapy

Outcome Description:

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.

Outcome Time Frame:

6 months

Safety Issue:

No

Principal Investigator

Mary Feng, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Michigan Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

UMCC 2007-110

NCT ID:

NCT01519232

Start Date:

August 2008

Completion Date:

January 2016

Related Keywords:

  • Hepatocellular Carcinoma
  • hepatocellular carcinoma
  • Carcinoma
  • Carcinoma, Hepatocellular

Name

Location

University of Michigan Comprehensive Cancer CenterAnn Arbor, Michigan  48109-0752