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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01213758
First Posted: October 4, 2010
Last Update Posted: October 30, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Danish Cancer Society
Information provided by (Responsible Party):
University of Aarhus
  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: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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 ]
    Volumetric uptake of FDGal can be measured is measured by PET/CT


Enrollment: 14
Study Start Date: June 2010
Study Completion Date: April 2016
Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with liver tumors reffered for stereotactic body radiation therapy
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Impaired kidney function
  • Pregnancy
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01213758


Locations
Denmark
Aarhus University Hospital
Aarhus C, Denmark, 8000
Sponsors and Collaborators
University of Aarhus
Danish Cancer Society
Investigators
Principal Investigator: Morten Høyer, MD PhD Aarhus University Hospital
  More Information

Additional Information:
Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT01213758     History of Changes
Other Study ID Numbers: AarhusLiverRadGal
First Submitted: October 1, 2010
First Posted: October 4, 2010
Last Update Posted: October 30, 2017
Last Verified: October 2017

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