Ignite Creation Date:
2025-12-24 @ 9:08 PM
Ignite Modification Date:
2025-12-29 @ 1:16 PM
Study NCT ID:
NCT01116804
Status:
COMPLETED
Last Update Posted:
2022-12-15
First Post:
2010-05-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Role PET Imaging in Response Assessment for Hepatocellular Carcinoma (HCC)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006528', 'term': 'Carcinoma, Hepatocellular'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-06-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2020-01-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-12-13', 'studyFirstSubmitDate': '2010-05-03', 'studyFirstSubmitQcDate': '2010-05-04', 'lastUpdatePostDateStruct': {'date': '2022-12-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-05-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-01-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To evaluate the efficacy of PET-imaging versus classic response assessment (MRI, CT-scam) in patients with inoperable liver cancer', 'timeFrame': '6 months after start of treatment'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Primary liver cancer'], 'conditions': ['Primary Liver Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.uzgent.be', 'label': 'website University Hospital Ghent'}]}, 'descriptionModule': {'briefSummary': 'Present imaging modalities for primary liver cancer (hepatocellular carcinoma or HCC) have several shortcomings. One important shortcoming is the time delay between successful treatment and radiological confirmation of this response. Often it takes several months for anatomical changes to occur and to be appreciated on morphological imaging such as CT or MRI (shrinkage of tumor, absence of contrast enhancement). Functional imaging by means of Fluor-18 deoxyglucose or Fluor-18 Choline (positron emitters, PET-scan) might be an early indicator of response. This "early" information might help to tailor treatment. For instance, if no response is induced, an early switch in therapy can be planned.\n\nThe present study investigates whether the routine PET-tracer (Fluor-18 deoxyglucose) and the experimental PET-tracer, Fluor-18 Choline help to predict response if a patient with inoperable primary liver cancer is treated (radionuclide therapy, biologicals).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria :\n\n* Male and female are eligible\n\n -\\>18years of age.No upper age limit.\n* not pregnant or breastfeeding\n* capable of understanding the study goals and protocol and to sign the informed consent.\n* Patients are diagnosed with primary liver cancer and referred for treatment with biologicals such as Sorafenib or treatment with radionuclides.'}, 'identificationModule': {'nctId': 'NCT01116804', 'briefTitle': 'Role PET Imaging in Response Assessment for Hepatocellular Carcinoma (HCC)', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Ghent'}, 'officialTitle': 'Role PET Imaging in Response Assessment for Hepatocellular Carcinoma (HCC)', 'orgStudyIdInfo': {'id': '2010/115'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'inoperable liver cancer patients', 'interventionNames': ['Procedure: MRI of the liver before start of treatment', 'Procedure: MRI after treatment', 'Procedure: PET-scan before treatment start', 'Procedure: PET scan after treatment']}], 'interventions': [{'name': 'MRI of the liver before start of treatment', 'type': 'PROCEDURE', 'description': 'MRI of the liver as classic work out of patients (CT-scan if MRI is contra-indicated)', 'armGroupLabels': ['inoperable liver cancer patients']}, {'name': 'MRI after treatment', 'type': 'PROCEDURE', 'description': 'MRI of the liver after 3 - 6 months of treatment (CT-scan if MRI is contra-indicated)', 'armGroupLabels': ['inoperable liver cancer patients']}, {'name': 'PET-scan before treatment start', 'type': 'PROCEDURE', 'description': 'PET-scan with 2 tracers is performed before treatment start', 'armGroupLabels': ['inoperable liver cancer patients']}, {'name': 'PET scan after treatment', 'type': 'PROCEDURE', 'description': 'PET-scan with 2 tracers is repeated 4 weeks following start of treatment', 'armGroupLabels': ['inoperable liver cancer patients']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ghent', 'country': 'Belgium', 'facility': 'University Hospital Ghent', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}], 'overallOfficials': [{'name': 'Bieke Lambert, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Ghent'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Ghent', 'class': 'OTHER'}, 'collaborators': [{'name': 'University Ghent', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}