Ignite Creation Date:
2025-12-25 @ 12:07 AM
Ignite Modification Date:
2025-12-25 @ 10:06 PM
Study NCT ID:
NCT01213758
Status:
COMPLETED
Last Update Posted:
2017-10-30
First Post:
2010-10-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Changes in Liver Function After Stereotactic Body Radiation Therapy Measured by PET/CT
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006528', 'term': 'Carcinoma, Hepatocellular'}, {'id': 'D018281', 'term': 'Cholangiocarcinoma'}, {'id': 'D009362', 'term': 'Neoplasm Metastasis'}], 'ancestors': [{'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008113', 'term': 'Liver Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-10-27', 'studyFirstSubmitDate': '2010-10-01', 'studyFirstSubmitQcDate': '2010-10-01', 'lastUpdatePostDateStruct': {'date': '2017-10-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-10-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Uptake of FDGal', 'timeFrame': 'Before, 1 month and 3 months after stereotactic radiotherapy', 'description': 'Volumetric uptake of FDGal can be measured is measured by PET/CT'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['liver function', 'galactose', '18-F-deoxy-galactose', 'PET/CT', 'stereotactic body radiation therapy', 'SBRT'], 'conditions': ['Hepatocellular Carcinoma', 'Cholangiocarcinoma', 'Metastases', 'Stereotactic Body Radiotherapy']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.cirro.dk', 'label': 'The Lundbeck Foundation Centre for Interventional Research in Radiation Oncology'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with liver tumors reffered for stereotactic body radiation therapy', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* liver tumor\n* referred for stereotactic radiation therapy\n* age \\> 18 years\n\nExclusion Criteria:\n\n* Impaired kidney function\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT01213758', 'briefTitle': 'Changes in Liver Function After Stereotactic Body Radiation Therapy Measured by PET/CT', 'organization': {'class': 'OTHER', 'fullName': 'University of Aarhus'}, 'officialTitle': 'Radiation Induced Change of Liver Function Measured by Uptake of the Galactose Analogue FDGal and PET/CT', 'orgStudyIdInfo': {'id': 'AarhusLiverRadGal'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Liver tumors', 'description': 'Patients where stereotactic body radiation therapy is planned for primary or metastatic liver tumors.', 'interventionNames': ['Other: Measuring liver function by PET/CT']}], 'interventions': [{'name': 'Measuring liver function by PET/CT', 'type': 'OTHER', 'description': 'Measuring liver function by use of FDGal and PET/CT before, 1 month and 3 months after stereotactic radiotherapy for liver tumors', 'armGroupLabels': ['Liver tumors']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8000', 'city': 'Aarhus C', 'country': 'Denmark', 'facility': 'Aarhus University Hospital', 'geoPoint': {'lat': 56.16558, 'lon': 10.21231}}], 'overallOfficials': [{'name': 'Morten Høyer, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Aarhus University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Aarhus', 'class': 'OTHER'}, 'collaborators': [{'name': 'Danish Cancer Society', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}