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

This study is currently recruiting participants.
Verified December 2013 by University of Michigan Cancer Center
Sponsor:
Information provided by (Responsible Party):
University of Michigan Cancer Center
ClinicalTrials.gov Identifier:
NCT01519232
First received: September 23, 2011
Last updated: December 9, 2013
Last verified: December 2013

September 23, 2011
December 9, 2013
August 2008
January 2015   (final data collection date for primary outcome measure)
Changes in hepatobiliary single photon emission tomography (SPECT) after radiation therapy [ Time Frame: 6 months ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01519232 on ClinicalTrials.gov Archive Site
measuring values between regional radiation dose and local hepatic function as measured by hepatobiliary SPECT, in normal liver parenchyma [ Time Frame: 6 months ] [ Designated as safety issue: No ]
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.
Same as current
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A Study of Changes in Hepatic Function During Radiation Therapy Using Hepatobiliary Single Photon Emission Tomography (SPECT)
A Pilot Study of Changes in Hepatic Function During Radiation Therapy Using Hepatobiliary 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.

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.

Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
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Probability Sample

cancer patients undergoing radiation of the Liver

Hepatocellular Carcinoma
Radiation: Liver Irradiation
Patients already scheduled to undergo radiation treatment
Liver Irradiation
patients already scheduled to undergo liver irradiation
Intervention: Radiation: Liver Irradiation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
20
January 2016
January 2015   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Mary Feng, MD (734) 936-7810
Contact: Cancer AnswerLine (800) 865-1125 canceranswerline@umich.edu
United States
 
NCT01519232
UMCC 2007-110, HUM00015656
Yes
University of Michigan Cancer Center
University of Michigan Cancer Center
Not Provided
Principal Investigator: Mary Feng, MD University of Michigan Cancer Center
University of Michigan Cancer Center
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP