Changes in Liver Function After Stereotactic Body Radiation Therapy Measured by PET/CT

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by University of Aarhus.
Recruitment status was  Recruiting
Danish Cancer Society
Information provided by (Responsible Party):
University of Aarhus Identifier:
First received: October 1, 2010
Last updated: March 21, 2012
Last verified: March 2012
Patients treated with stereotactic radiotherapy for liver tumors undergo PET/CT using the galactose analogue 18-F-deoxy-galactose (FDGal) before and after radiotherapy. This technique provides volumetric mapping of liver function and it allows quantisation of liver function. The method may be used for selection of patients for stereotactic radiotherapy of liver tumors, for determination of radiation induced liver dysfunction and may be included into the treatment planning process of stereotactic radiotherapy.

Condition Intervention
Hepatocellular Carcinoma
Stereotactic Body Radiotherapy
Other: Measuring liver function by PET/CT

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Radiation Induced Change of Liver Function Measured by Uptake of the Galactose Analogue FDGal and PET/CT

Resource links provided by NLM:

Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • Uptake of FDGal [ Time Frame: Before, 1 month and 3 months after stereotactic radiotherapy ] [ Designated as safety issue: No ]
    Volumetric uptake of FDGal can be measured is measured by PET/CT

Estimated Enrollment: 20
Study Start Date: June 2010
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Liver tumors
Patients where stereotactic body radiation therapy is planned for primary or metastatic liver tumors.
Other: Measuring liver function by PET/CT
Measuring liver function by use of FDGal and PET/CT before, 1 month and 3 months after stereotactic radiotherapy for liver tumors


Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • liver tumor
  • referred for stereotactic radiation therapy
  • age > 18 years

Exclusion Criteria:

  • Impaired kidney function
  • Pregnancy
  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 identifier: NCT01213758

Contact: Morten Høyer, MD PhD +45 89492529

Aarhus University Hospital Recruiting
Aarhus C, Denmark, 8000
Contact: Morten Høyer, MD PhD    +45 89492529   
Sponsors and Collaborators
University of Aarhus
Danish Cancer Society
Principal Investigator: Morten Høyer, MD PhD Aarhus University Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: University of Aarhus Identifier: NCT01213758     History of Changes
Other Study ID Numbers: AarhusLiverRadGal
Study First Received: October 1, 2010
Last Updated: March 21, 2012
Health Authority: Denmark: National Board of Health

Keywords provided by University of Aarhus:
liver function
stereotactic body radiation therapy

Additional relevant MeSH terms:
Carcinoma, Hepatocellular
Digestive System Diseases
Digestive System Neoplasms
Liver Diseases
Liver Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Liver Extracts
Hematologic Agents
Pharmacologic Actions
Therapeutic Uses processed this record on November 30, 2015