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:
University of Aarhus
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
| Tracking Information | |||||
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| First Received Date ICMJE | October 1, 2010 | ||||
| Last Updated Date | March 21, 2012 | ||||
| Start Date ICMJE | June 2010 | ||||
| Estimated Primary Completion Date | January 2013 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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 |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01213758 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Changes in Liver Function After Stereotactic Body Radiation Therapy Measured by PET/CT | ||||
| Official Title ICMJE | Radiation Induced Change of Liver Function Measured by Uptake of the Galactose Analogue FDGal and PET/CT | ||||
| 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
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| Condition ICMJE |
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| Intervention ICMJE | 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 |
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| Study Arm (s) | No Intervention: Liver tumors
Patients where stereotactic body radiation therapy is planned for primary or metastatic liver tumors.
Intervention: Other: Measuring liver function by PET/CT |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 20 | ||||
| Estimated Completion Date | May 2013 | ||||
| Estimated Primary Completion Date | January 2013 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 85 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | Denmark | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01213758 | ||||
| Other Study ID Numbers ICMJE | AarhusLiverRadGal | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | University of Aarhus | ||||
| Study Sponsor ICMJE | University of Aarhus | ||||
| Collaborators ICMJE | Danish Cancer Society | ||||
| Investigators ICMJE |
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| Information Provided By | University of Aarhus | ||||
| Verification Date | March 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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