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

Hepatocellular Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01519232
• Other study ID #: UMCC 2007-110
• Secondary ID: HUM00015656
• Status: Completed
• Phase: N/A
• First received: September 23, 2011
• Last updated: May 14, 2015
• Start date: August 2008
• Est. completion date: May 2014

Study information

• Verified date: May 2015
• Source: University of Michigan Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: May 2014
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Radiation:
• Liver Irradiation
Patients already scheduled to undergo radiation treatment

Locations

Country	Name	City	State
United States	University of Michigan Comprehensive Cancer Center	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in hepatobiliary single photon emission tomography (SPECT) after radiation therapy	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.	6 months	No
Secondary	measuring values between regional radiation dose and local hepatic function as measured by hepatobiliary SPECT, in normal liver parenchyma	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.	6 months	No