- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01213758
Changes in Liver Function After Stereotactic Body Radiation Therapy Measured by PET/CT
October 27, 2017 updated by: University of Aarhus
Radiation Induced Change of Liver Function Measured by Uptake of the Galactose Analogue FDGal and PET/CT
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.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
14
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Aarhus C, Denmark, 8000
- Aarhus University Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Patients with liver tumors reffered for stereotactic body radiation therapy
Description
Inclusion Criteria:
- liver tumor
- referred for stereotactic radiation therapy
- age > 18 years
Exclusion Criteria:
- Impaired kidney function
- Pregnancy
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Liver tumors
Patients where stereotactic body radiation therapy is planned for primary or metastatic liver tumors.
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Measuring liver function by use of FDGal and PET/CT before, 1 month and 3 months after stereotactic radiotherapy for liver tumors
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Uptake of FDGal
Time Frame: Before, 1 month and 3 months after stereotactic radiotherapy
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Volumetric uptake of FDGal can be measured is measured by PET/CT
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Before, 1 month and 3 months after stereotactic radiotherapy
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Morten Høyer, MD PhD, Aarhus University Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2010
Primary Completion (Actual)
April 1, 2016
Study Completion (Actual)
April 1, 2016
Study Registration Dates
First Submitted
October 1, 2010
First Submitted That Met QC Criteria
October 1, 2010
First Posted (Estimate)
October 4, 2010
Study Record Updates
Last Update Posted (Actual)
October 30, 2017
Last Update Submitted That Met QC Criteria
October 27, 2017
Last Verified
October 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AarhusLiverRadGal
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.