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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by University of Michigan Cancer Center
Sponsor:
Information provided by (Responsible Party):
Mary Feng, University of Michigan Cancer Center
ClinicalTrials.gov Identifier:
NCT01519232
First received: September 23, 2011
Last updated: July 10, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention
Hepatocellular Carcinoma
Radiation: Liver Irradiation

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Pilot Study of Changes in Hepatic Function During Radiation Therapy Using Hepatobiliary SPECT

Resource links provided by NLM:


Further study details as provided by University of Michigan Cancer Center:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 20
Study Start Date: August 2008
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Liver Irradiation
patients already scheduled to undergo liver irradiation
Radiation: Liver Irradiation
Patients already scheduled to undergo radiation treatment

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

cancer patients undergoing radiation of the Liver

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01519232

Contacts
Contact: Mary Feng, MD (734) 936-7810
Contact: Cancer AnswerLine (800) 865-1125 canceranswerline@umich.edu

Locations
United States, Michigan
University of Michigan Comprehensive Cancer Center Recruiting
Ann Arbor, Michigan, United States, 48109-5010
Contact: Mary Feng, MD    734-615-4909      
Contact: Cancer AnswerLine    (800) 865-1125    canceranswerline@umich.edu   
Sponsors and Collaborators
Mary Feng
Investigators
Principal Investigator: Mary Feng, MD University of Michigan Cancer Center
  More Information

No publications provided

Responsible Party: Mary Feng, Principal Investigator, University of Michigan Cancer Center
ClinicalTrials.gov Identifier: NCT01519232     History of Changes
Other Study ID Numbers: UMCC 2007-110, HUM00015656
Study First Received: September 23, 2011
Last Updated: July 10, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Michigan Cancer Center:
hepatocellular carcinoma

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Hepatocellular
Adenocarcinoma
Digestive System Diseases
Digestive System Neoplasms
Liver Diseases
Liver Neoplasms
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on October 22, 2014