Ignite Creation Date:
2025-12-24 @ 11:04 PM
Ignite Modification Date:
2026-02-25 @ 6:59 PM
Study NCT ID:
NCT03303469
Status:
TERMINATED
Last Update Posted:
2021-02-21
First Post:
2017-09-13
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Hypoxic Changes in Hepatocellular Carcinoma (HCC) Following Trans Arterial Chemo Embolization and Stereotactic Radiation: Fluorine18 (18F) Fluoromisonidazole (FMISO) Imaging
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2021-02-16', 'type': 'ACTUAL'}}}}, '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C031843', 'term': 'fluoromisonidazole'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jomalley@uabmc.edu', 'phone': '205-934-6504', 'title': "Janis O'Malley", 'organization': 'The University of Alabama at Birmingham'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Between 4 to 6 weeks.', 'eventGroups': [{'id': 'EG000', 'title': 'FMISO PET Imaging Post TACE and SBRT', 'description': 'FMISO imaging at baseline, post-TACE and post-SBRT\n\nFMISO: FMISO PET/CT imaging at baseline\n\nFMISO: FMISO PET/CT post TACE\n\nFMISO: FMISO PET/CT post SBRT', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 0, 'seriousNumAtRisk': 3, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '3'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Quantitate HCC Tumor Hypoxia at Baseline Using FMISO Positron Emission Tomography (PET).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'FMISO PET Imaging Post TACE and SBRT', 'description': 'FMISO imaging at baseline, post-TACE and post-SBRT\n\nFMISO: FMISO PET/CT imaging at baseline\n\nFMISO: FMISO PET/CT post TACE\n\nFMISO: FMISO PET/CT post SBRT'}], 'timeFrame': 'At baseline', 'description': 'Perform PET/CT imaging using FMISO at baseline to measure tumor hypoxia', 'reportingStatus': 'POSTED', 'populationDescription': 'We were unable to perform the statistical analysis due to insufficient data collection.'}, {'type': 'PRIMARY', 'title': 'Measure Changes in HCC Tumor Hypoxia and Blood Flow After Trans-arterial Chemoembolization (TACE), Prior to Radiotherapy.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'FMISO PET Imaging Post TACE and SBRT', 'description': 'FMISO imaging at baseline, post-TACE and post-SBRT\n\nFMISO: FMISO PET/CT imaging at baseline\n\nFMISO: FMISO PET/CT post TACE\n\nFMISO: FMISO PET/CT post SBRT'}], 'timeFrame': '1 month post-TACE procedures and prior to SBRT', 'description': 'Perform PET/CT imaging using FMISO post-TACE and prior to Stereotactic body radiation therapy (SBRT) to determine tumor hypoxia', 'reportingStatus': 'POSTED', 'populationDescription': 'We were unable to perform the statistical analysis due to insufficient data collection.'}, {'type': 'PRIMARY', 'title': 'Measure Changes in Treated HCC Tumor Hypoxia Following TACE and Radiotherapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'FMISO PET Imaging Post TACE and SBRT', 'description': 'FMISO imaging at baseline, post-TACE and post-SBRT\n\nFMISO: FMISO PET/CT imaging at baseline\n\nFMISO: FMISO PET/CT post TACE\n\nFMISO: FMISO PET/CT post SBRT'}], 'timeFrame': '1 month post-SBRT', 'description': 'Perform PET/CT imaging using FMISO post-SBRT to determine tumor hypoxia', 'reportingStatus': 'POSTED', 'populationDescription': 'We were unable to perform the statistical analysis due to insufficient data collection.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'FMISO PET Imaging Post TACE and SBRT', 'description': 'FMISO imaging at baseline, post-TACE and post-SBRT\n\nFMISO: FMISO PET/CT imaging at baseline\n\nFMISO: FMISO PET/CT post TACE\n\nFMISO: FMISO PET/CT post SBRT'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'FMISO PET Imaging Post TACE and SBRT', 'description': 'FMISO imaging at baseline, post-TACE and post-SBRT\n\nFMISO: FMISO PET/CT imaging at baseline\n\nFMISO: FMISO PET/CT post TACE\n\nFMISO: FMISO PET/CT post SBRT'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-07-30', 'size': 3777867, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-02-15T10:15', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3}}, 'statusModule': {'whyStopped': 'study was terminated due to poor enrollment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2017-10-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2021-01-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-15', 'studyFirstSubmitDate': '2017-09-13', 'resultsFirstSubmitDate': '2021-01-27', 'studyFirstSubmitQcDate': '2017-10-02', 'lastUpdatePostDateStruct': {'date': '2021-02-21', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-02-15', 'studyFirstPostDateStruct': {'date': '2017-10-06', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-02-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-01-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quantitate HCC Tumor Hypoxia at Baseline Using FMISO Positron Emission Tomography (PET).', 'timeFrame': 'At baseline', 'description': 'Perform PET/CT imaging using FMISO at baseline to measure tumor hypoxia'}, {'measure': 'Measure Changes in HCC Tumor Hypoxia and Blood Flow After Trans-arterial Chemoembolization (TACE), Prior to Radiotherapy.', 'timeFrame': '1 month post-TACE procedures and prior to SBRT', 'description': 'Perform PET/CT imaging using FMISO post-TACE and prior to Stereotactic body radiation therapy (SBRT) to determine tumor hypoxia'}, {'measure': 'Measure Changes in Treated HCC Tumor Hypoxia Following TACE and Radiotherapy', 'timeFrame': '1 month post-SBRT', 'description': 'Perform PET/CT imaging using FMISO post-SBRT to determine tumor hypoxia'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hepatocellular Carcinoma']}, 'descriptionModule': {'briefSummary': '\\[18F\\] FMISO Positron Emission Tomography (PET) to determine hypoxia in patients with HCC treated with TACE.', 'detailedDescription': 'This Phase II study will investigate the utility of \\[18F\\] FMISO in patients with hepatocellular carcinoma (HCC). This trial is designed to test the hypothesis that PET determined \\[18F\\]FMISO uptake will indicate tumor hypoxia in patients with HCC treated with trans-arterial chemo-embolization (TACE). We anticipate that \\[18F\\] FMISO PET/CT will advance our understanding of the role of hypoxia in HCC prior to treatment and that this knowledge will help design newer combination therapeutic trials for better treatment outcomes. \\[18F\\] FMISO PET/CT provides three parameters, tissue hypoxic volume (HV), maximum tissue to blood uptake ratio (T:Bmax) and tumor blood flow. Both pre-and post-therapy images will be examined to investigate changes in these parameters during the course of TACE treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult (\\> 18 years of age) patients with documented HCC tumor mass \\>3cm, who are scheduled to undergo TACE with additional selective internal radiation therapy (SIRT)\n* The appropriate criteria for inclusion for this patient population are:\n* Biopsy or radiological diagnosis of HCC (defined as Organ Procurement and Transplantation Network (OPTN\\*) Category 5 lesion either on CT or MRI)\n* Scheduled for TACE (using doxorubicin-eluting beads) + SBRT\n* Willingness to undergo PET/CT\n* Able to lie on the imaging table for up to 1 hour.\n* Able to provide signed informed consent.\n* Women with childbearing potential must have a negative urine Beta-Human Chorionic Gonadotropin (β-hCG) test day of procedure\n\nExclusion Criteria:\n\n* Estimated life expectancy \\<12 months or serious medical co-morbidities that would preclude definitive local therapy\n* Unable to lie on the imaging table\n* Age less than 18 years.\n* Pregnancy or lactation\n* Inability or unwillingness to provide informed consent.\n* Weight \\>500 lbs (the weight limit of the tomograph gantry table)'}, 'identificationModule': {'nctId': 'NCT03303469', 'briefTitle': 'Hypoxic Changes in Hepatocellular Carcinoma (HCC) Following Trans Arterial Chemo Embolization and Stereotactic Radiation: Fluorine18 (18F) Fluoromisonidazole (FMISO) Imaging', 'organization': {'class': 'OTHER', 'fullName': 'University of Alabama at Birmingham'}, 'officialTitle': 'Hypoxic Changes in Hepatocellular Carcinoma (HCC) Following Trans Arterial Chemo Embolization and Stereotactic Radiation: [18F]Fluoromisonidazole (FMISO) Imaging', 'orgStudyIdInfo': {'id': 'F170519002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'FMISO PET imaging post TACE and Stereotactic body radiation therapy (SBRT)', 'description': 'FMISO imaging at baseline, post-TACE and post-SBRT', 'interventionNames': ['Drug: FMISO']}], 'interventions': [{'name': 'FMISO', 'type': 'DRUG', 'description': 'FMISO PET/CT imaging at baseline', 'armGroupLabels': ['FMISO PET imaging post TACE and Stereotactic body radiation therapy (SBRT)']}, {'name': 'FMISO', 'type': 'DRUG', 'description': 'FMISO PET/CT post TACE', 'armGroupLabels': ['FMISO PET imaging post TACE and Stereotactic body radiation therapy (SBRT)']}, {'name': 'FMISO', 'type': 'DRUG', 'description': 'FMISO PET/CT post SBRT', 'armGroupLabels': ['FMISO PET imaging post TACE and Stereotactic body radiation therapy (SBRT)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'UAB Advanced Imaging Facility', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}], 'overallOfficials': [{'name': "Janis P O'Malley, M.D.", 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Alabama at Birmingham'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Alabama at Birmingham', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator, Professor of Radiology', 'investigatorFullName': "Janis P. O'Malley, MD", 'investigatorAffiliation': 'University of Alabama at Birmingham'}}}}