Text Size

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

This study is currently recruiting participants.
Verified March 2012 by University of Aarhus
Sponsor:
Collaborator:
Danish Cancer Society
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT01213758
First received: October 1, 2010
Last updated: March 21, 2012
Last verified: March 2012
History of Changes
  Purpose

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
Cholangiocarcinoma
Metastases
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:

MedlinePlus related topics: Cancer Liver Cancer
U.S. FDA Resources

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

  Eligibility

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

Inclusion Criteria:

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

Exclusion Criteria:

  • Impaired kidney function
  • Pregnancy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01213758

Contacts
Contact: Morten Høyer, MD PhD +45 89492529 hoyer@aarhus.rm.dk

Locations
Denmark
Aarhus University Hospital Recruiting
Aarhus C, Denmark, 8000
Contact: Morten Høyer, MD PhD     +45 89492529     hoyer@aarhus.rm.dk    
Sponsors and Collaborators
University of Aarhus
Danish Cancer Society
Investigators
Principal Investigator: Morten Høyer, MD PhD Aarhus University Hospital
  More Information

Additional Information:
The Lundbeck Foundation Centre for Interventional Research in Radiation Oncology  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: University of Aarhus
ClinicalTrials.gov 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
galactose
18-F-deoxy-galactose
 PET/CT
stereotactic body radiation therapy
SBRT

Additional relevant MeSH terms:
Carcinoma
Neoplasm Metastasis
Cholangiocarcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplastic Processes
 Pathologic Processes
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases

ClinicalTrials.gov processed this record on May 16, 2013