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NCT Number: NCT01519232

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.

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Key information

Conditions

Hepatocellular Carcinoma Adenocarcinoma Carcinoma Carcinoma, Hepatocellular Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109-5010, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Liver Irradiation

Radiation

Patients already scheduled to undergo radiation treatment

Primary outcomes

  1. 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 outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University of Michigan Rogel Cancer Center

Other

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2012
Study completion
2014
First posted
Jan 26, 2012
Registry last updated
May 18, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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