Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 9 of 81692 for:    measured
Previous Study | Return to List | Next Study

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

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.
 
ClinicalTrials.gov Identifier: NCT01213758
Recruitment Status : Completed
First Posted : October 4, 2010
Last Update Posted : October 30, 2017
Sponsor:
Collaborator:
Danish Cancer Society
Information provided by (Responsible Party):
University of Aarhus

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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 or disease Intervention/treatment
Hepatocellular Carcinoma Cholangiocarcinoma Metastases Stereotactic Body Radiotherapy Other: Measuring liver function by PET/CT

Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Actual Enrollment : 14 participants
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
Study Start Date : June 2010
Actual Primary Completion Date : April 2016
Actual Study Completion Date : April 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Liver Cancer

Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort Intervention/treatment
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


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
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
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Layout table for location information
Denmark
Aarhus University Hospital
Aarhus C, Denmark, 8000
Sponsors and Collaborators
University of Aarhus
Danish Cancer Society
Investigators
Layout table for investigator information
Principal Investigator: Morten Høyer, MD PhD Aarhus University Hospital
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Layout table for additonal information
Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT01213758     History of Changes
Other Study ID Numbers: AarhusLiverRadGal
First Posted: October 4, 2010    Key Record Dates
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:
Layout table for MeSH terms
Carcinoma, Hepatocellular
Cholangiocarcinoma
Neoplasms
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
 Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Liver Extracts
Hematinics