Ignite Creation Date:
2025-12-24 @ 9:19 PM
Ignite Modification Date:
2025-12-25 @ 7:07 PM
Study NCT ID:
NCT00019604
Status:
TERMINATED
Last Update Posted:
2017-02-03
First Post:
2001-07-11
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Radiofrequency Ablation in Treating Patients With Unresectable Primary or Metastatic Liver Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008113', 'term': 'Liver Neoplasms'}, {'id': 'D009362', 'term': 'Neoplasm Metastasis'}, {'id': 'D006528', 'term': 'Carcinoma, Hepatocellular'}], 'ancestors': [{'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'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'}, {'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009682', 'term': 'Magnetic Resonance Spectroscopy'}, {'id': 'D000078703', 'term': 'Radiofrequency Ablation'}, {'id': 'D019220', 'term': 'High-Energy Shock Waves'}, {'id': 'D019788', 'term': 'Fluorodeoxyglucose F18'}, {'id': 'D019786', 'term': 'Gadolinium DTPA'}], 'ancestors': [{'id': 'D013057', 'term': 'Spectrum Analysis'}, {'id': 'D002623', 'term': 'Chemistry Techniques, Analytical'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D000078702', 'term': 'Radiofrequency Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D055011', 'term': 'Ablation Techniques'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D000069453', 'term': 'Ultrasonic Waves'}, {'id': 'D013016', 'term': 'Sound'}, {'id': 'D011840', 'term': 'Radiation, Nonionizing'}, {'id': 'D011827', 'term': 'Radiation'}, {'id': 'D055585', 'term': 'Physical Phenomena'}, {'id': 'D003847', 'term': 'Deoxyglucose'}, {'id': 'D003837', 'term': 'Deoxy Sugars'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D004369', 'term': 'Pentetic Acid'}, {'id': 'D011073', 'term': 'Polyamines'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000085', 'term': 'Acetates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D056831', 'term': 'Coordination Complexes'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'steaklec@mail.nih.gov', 'phone': '301-435-3685', 'title': 'Caryn Steakley', 'organization': 'National Cancer Institute, National Institutes of Health'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Adverse event data is available but the format is uninterpretable.'}}, 'adverseEventsModule': {'description': 'Number zero is entered for the total number of participants with adverse events because it is unknown. Adverse event data is available but it is uninterpretable, thus no Serious or Other adverse events are entered for this module.', 'eventGroups': [{'id': 'EG000', 'title': 'Radiofrequency Ablation in Liver Cancer', 'description': 'This trial is designed to gain experience with the use of ablation devices with liver tumors. Radiofrequency ablation is a procedure that heats tumors to several degrees above body temperature and may kill tumor cells.', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Radiofrequency Ablation in Liver Cancer', 'description': 'This trial is designed to gain experience with the use of ablation devices with liver tumors. Radiofrequency ablation is a procedure that heats tumors to several degrees above body temperature and may kill tumor cells.'}], 'classes': [{'title': 'Complete Response', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Partial Response', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Minor Response', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Stable Disease', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Progressive Disease', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'description': 'Standard response criteria will be used to assess the CT (computed tomography) scan images on a lesion per lesion basis. Complete response is complete disappearance of the index lesion on followup scan when compared to the pretreatment images. Partial response is a decrease of 50% or greater in the product of the perpendicular diameters of the measured lesion following treatment compared to the pretreatment images. Minor response is a decrease between 25% and 49% in the product of the perpendicular diameters of the measured lesion following treatment compared to the pretreatment images. Stable disease is no change in the size of the treated lesion. Progressive disease is an increase of greater than 25% in the product of the perpendicular diameters of the measured lesion following treatment compared to the pretreatment images.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The time frame for this outcome measure is unknown; the investigator left the institution and there is no available data. We only have access available on 23 participants. We cannot comment on the others or verify because we do not have the data.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Radiofrequency Ablation in Liver Cancer', 'description': 'This trial is designed to gain experience with the use of ablation devices with liver tumors. Radiofrequency ablation is a procedure that heats tumors to several degrees above body temperature and may kill tumor cells.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Adverse event data is available but the format is uninterpretable.', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '9 years, 9 months', 'description': 'Here is the number of participants with adverse events. For a detailed list of adverse events see the adverse event module.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'NA is entered for the total number of participants with adverse events because it is unknown. Adverse event data is available but the format is uninterpretable.'}, {'type': 'SECONDARY', 'title': 'Tumor Blood Flow', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Radiofrequency Ablation in Liver Cancer', 'description': 'This trial is designed to gain experience with the use of ablation devices with liver tumors. Radiofrequency ablation is a procedure that heats tumors to several degrees above body temperature and may kill tumor cells.'}], 'timeFrame': 'Baseline, 3 months, and 6 months following treatment', 'description': 'Tumor blood flow was to be assessed by magnetic resonance imaging (MRI) and compared to data collected on baseline pretreatment images and other appropriate time points for changes in tumor microvascular density.', 'reportingStatus': 'POSTED', 'populationDescription': 'This outcome measure was not analyzed because the investigator left the institution and the study never completed; all participants were taken off study.'}, {'type': 'SECONDARY', 'title': 'Tumor Vascular Density', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Radiofrequency Ablation in Liver Cancer', 'description': 'This trial is designed to gain experience with the use of ablation devices with liver tumors. Radiofrequency ablation is a procedure that heats tumors to several degrees above body temperature and may kill tumor cells.'}], 'timeFrame': 'Baseline, 3 months, and 6 months following treatment', 'description': 'Tumor vascular density was to be assessed by magnetic resonance imaging (MRI) and compared to data collected on baseline pretreatment images and other appropriate time points for changes in tumor microvascular density. Patterns of MRI contrast uptake within tumors correlate with microvessel density.', 'reportingStatus': 'POSTED', 'populationDescription': 'This outcome measure was not analyzed because the investigator left the institution and the study never completed; all participants were taken off study.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With a Response Using Fludeoxyglucose (18F) - Positron Emission Tomography (FDG-PET) Following Radiofrequency Ablation (RFA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Radiofrequency Ablation in Liver Cancer', 'description': 'This trial is designed to gain experience with the use of ablation devices with liver tumors. Radiofrequency ablation is a procedure that heats tumors to several degrees above body temperature and may kill tumor cells.'}], 'timeFrame': 'Baseline, 6 weeks, 3 months, and 6 months following treatment', 'description': 'Response was to be evaluated by the standard response criteria. Complete response is the complete disappearance of the index lesion on follow-up scan when compared to the pretreatment images. Partial response is a decrease of 50% or greater in the product of the perpendicular diameters of the measured lesion following treatment compared to the pretreatment images. Minor response is a decrease between 25% and 49% in the product of the perpendicular diameters of the measured lesion following treatment compared to the pretreatment images. Stable disease is no change in the size of the treated lesion. Progressive disease is an increase of greater than 25% in the product of the perpendicular diameters of the measured lesion following treatment compared to the pretreatment images.', 'reportingStatus': 'POSTED', 'populationDescription': 'This outcome measure was not analyzed because the investigator left the institution and the study never completed; all participants were taken off study.'}, {'type': 'SECONDARY', 'title': 'Compare Fludeoxyglucose (18F) Positron-Emission Tomography (FDG-PET) Results With Computed Tomography (CT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Radiofrequency Ablation in Liver Cancer', 'description': 'This trial is designed to gain experience with the use of ablation devices with liver tumors. Radiofrequency ablation is a procedure that heats tumors to several degrees above body temperature and may kill tumor cells.'}], 'timeFrame': 'Baseline, 6 weeks, 3 months, and 6 months following treatment', 'description': 'Participants were to undergo FDG-PET scanning and CT scans to compare changes in size of metabolically active volume and standard uptake value (tumor metabolism).', 'reportingStatus': 'POSTED', 'populationDescription': 'This outcome measure was not analyzed because the investigator left the institution and the study never completed; all participants were taken off study.'}, {'type': 'SECONDARY', 'title': 'Compare Fludeoxyglucose (18F) Positron-Emission Tomography (FDG-PET) Results With Biopsies', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Radiofrequency Ablation in Liver Cancer', 'description': 'This trial is designed to gain experience with the use of ablation devices with liver tumors. Radiofrequency ablation is a procedure that heats tumors to several degrees above body temperature and may kill tumor cells.'}], 'timeFrame': 'Baseline, 6 weeks, 3 months, and 6 months following treatment', 'description': 'Participants were to undergo tissue biopsies of tumor to quantify changes in the tumor to see if the changes we see on the imaging studies are the same as the changes in the tumor.', 'reportingStatus': 'POSTED', 'populationDescription': 'This outcome measure was not analyzed because the investigator left the institution and the study never completed; all participants were taken off study.'}, {'type': 'SECONDARY', 'title': 'Compare Fludeoxyglucose (18F) Positron-Emission Tomography (FDG-PET) Results With Serum Markers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Radiofrequency Ablation in Liver Cancer', 'description': 'This trial is designed to gain experience with the use of ablation devices with liver tumors. Radiofrequency ablation is a procedure that heats tumors to several degrees above body temperature and may kill tumor cells.'}], 'timeFrame': 'Baseline, 6 weeks, 3 months, and 6 months following treatment', 'description': 'Images obtained by the FDG-PET was to be processed for changes in measured parameters and quantified compared to serum markers at baseline and appropriate follow-up points.', 'reportingStatus': 'POSTED', 'populationDescription': 'This outcome measure was not analyzed because the investigator left the institution and the study never completed; all participants were taken off study.'}, {'type': 'SECONDARY', 'title': 'Compare the Performance of Fludeoxyglucose (18F) Positron-Emission Tomography to Computed Tomography and Magnetic Resonance Imaging With Respect to Their Ability to Assess the Effects of Radiofrequency Ablation on the Treatment of Hepatic Neoplasms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Radiofrequency Ablation in Liver Cancer', 'description': 'This trial is designed to gain experience with the use of ablation devices with liver tumors. Radiofrequency ablation is a procedure that heats tumors to several degrees above body temperature and may kill tumor cells.'}], 'timeFrame': 'Baseline, 6 weeks, 3 months, and 6 months following treatment', 'description': 'Images obtained by the FDG-PET, MRI and CT was to be processed for changes in measured parameters and quantified compared to baseline (e.g., \\<median change, \\>median change in size on CT, computed by subtracting the baseline value from the value at the appropriate follow-up point).', 'reportingStatus': 'POSTED', 'populationDescription': 'This outcome measure was not analyzed because the investigator left the institution and the study never completed; all participants were taken off study.'}, {'type': 'SECONDARY', 'title': 'Evaluate the Ability of Fludeoxyglucose (18F) Positron-Emission Tomography (FDG-PET) to Monitor Response Following Radiofrequency Ablation (RFA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Radiofrequency Ablation in Liver Cancer', 'description': 'This trial is designed to gain experience with the use of ablation devices with liver tumors. Radiofrequency ablation is a procedure that heats tumors to several degrees above body temperature and may kill tumor cells.'}], 'timeFrame': 'Baseline, 6 weeks, 3 months, and 6 months following treatment', 'description': 'PET scan images was to be read by a physician experienced in the interpretation of whole body PET imaging. The region of interest was to be performed in any abnormal sites of uptake that is a candidate and or has been RFA ablated.', 'reportingStatus': 'POSTED', 'populationDescription': 'This outcome measure was not analyzed because the investigator left the institution and the study never completed; all participants were taken off study.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Radiofrequency Ablation in Liver Cancer', 'description': 'This trial is designed to gain experience with the use of ablation devices with liver tumors. Radiofrequency ablation is a procedure that heats tumors to several degrees above body temperature and may kill tumor cells.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '44'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '39'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Progressive disease', 'reasons': [{'groupId': 'FG000', 'numSubjects': '23'}]}, {'type': 'Refused treatment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Carcinoid tumor, not treatable', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Going to have liver transplant', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Move to a different study', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Non compliant on systemic CH', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Non compliant', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Resectable disease', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Started new chemo regimen', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Pt going to immunotherapy study', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Too much disease', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Unable to evaluate', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Details for other not available', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Radiofrequency Ablation in Liver Cancer', 'description': 'This trial is designed to gain experience with the use of ablation devices with liver tumors. Radiofrequency ablation is a procedure that heats tumors to several degrees above body temperature and may kill tumor cells.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '27', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '17', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '59.18', 'spread': '13.19', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Gender', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '21', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '23', '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': '44', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '35', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', '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': '44', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 44}}, 'statusModule': {'whyStopped': 'Principal investigator left the institution.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '1998-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-12', 'completionDateStruct': {'date': '2009-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-12-07', 'studyFirstSubmitDate': '2001-07-11', 'resultsFirstSubmitDate': '2014-04-01', 'studyFirstSubmitQcDate': '2003-01-26', 'lastUpdatePostDateStruct': {'date': '2017-02-03', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-05-13', 'studyFirstPostDateStruct': {'date': '2003-01-27', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-06-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Response', 'description': 'Standard response criteria will be used to assess the CT (computed tomography) scan images on a lesion per lesion basis. Complete response is complete disappearance of the index lesion on followup scan when compared to the pretreatment images. Partial response is a decrease of 50% or greater in the product of the perpendicular diameters of the measured lesion following treatment compared to the pretreatment images. Minor response is a decrease between 25% and 49% in the product of the perpendicular diameters of the measured lesion following treatment compared to the pretreatment images. Stable disease is no change in the size of the treated lesion. Progressive disease is an increase of greater than 25% in the product of the perpendicular diameters of the measured lesion following treatment compared to the pretreatment images.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Adverse Events', 'timeFrame': '9 years, 9 months', 'description': 'Here is the number of participants with adverse events. For a detailed list of adverse events see the adverse event module.'}, {'measure': 'Tumor Blood Flow', 'timeFrame': 'Baseline, 3 months, and 6 months following treatment', 'description': 'Tumor blood flow was to be assessed by magnetic resonance imaging (MRI) and compared to data collected on baseline pretreatment images and other appropriate time points for changes in tumor microvascular density.'}, {'measure': 'Tumor Vascular Density', 'timeFrame': 'Baseline, 3 months, and 6 months following treatment', 'description': 'Tumor vascular density was to be assessed by magnetic resonance imaging (MRI) and compared to data collected on baseline pretreatment images and other appropriate time points for changes in tumor microvascular density. Patterns of MRI contrast uptake within tumors correlate with microvessel density.'}, {'measure': 'Percentage of Participants With a Response Using Fludeoxyglucose (18F) - Positron Emission Tomography (FDG-PET) Following Radiofrequency Ablation (RFA)', 'timeFrame': 'Baseline, 6 weeks, 3 months, and 6 months following treatment', 'description': 'Response was to be evaluated by the standard response criteria. Complete response is the complete disappearance of the index lesion on follow-up scan when compared to the pretreatment images. Partial response is a decrease of 50% or greater in the product of the perpendicular diameters of the measured lesion following treatment compared to the pretreatment images. Minor response is a decrease between 25% and 49% in the product of the perpendicular diameters of the measured lesion following treatment compared to the pretreatment images. Stable disease is no change in the size of the treated lesion. Progressive disease is an increase of greater than 25% in the product of the perpendicular diameters of the measured lesion following treatment compared to the pretreatment images.'}, {'measure': 'Compare Fludeoxyglucose (18F) Positron-Emission Tomography (FDG-PET) Results With Computed Tomography (CT)', 'timeFrame': 'Baseline, 6 weeks, 3 months, and 6 months following treatment', 'description': 'Participants were to undergo FDG-PET scanning and CT scans to compare changes in size of metabolically active volume and standard uptake value (tumor metabolism).'}, {'measure': 'Compare Fludeoxyglucose (18F) Positron-Emission Tomography (FDG-PET) Results With Biopsies', 'timeFrame': 'Baseline, 6 weeks, 3 months, and 6 months following treatment', 'description': 'Participants were to undergo tissue biopsies of tumor to quantify changes in the tumor to see if the changes we see on the imaging studies are the same as the changes in the tumor.'}, {'measure': 'Compare Fludeoxyglucose (18F) Positron-Emission Tomography (FDG-PET) Results With Serum Markers', 'timeFrame': 'Baseline, 6 weeks, 3 months, and 6 months following treatment', 'description': 'Images obtained by the FDG-PET was to be processed for changes in measured parameters and quantified compared to serum markers at baseline and appropriate follow-up points.'}, {'measure': 'Compare the Performance of Fludeoxyglucose (18F) Positron-Emission Tomography to Computed Tomography and Magnetic Resonance Imaging With Respect to Their Ability to Assess the Effects of Radiofrequency Ablation on the Treatment of Hepatic Neoplasms', 'timeFrame': 'Baseline, 6 weeks, 3 months, and 6 months following treatment', 'description': 'Images obtained by the FDG-PET, MRI and CT was to be processed for changes in measured parameters and quantified compared to baseline (e.g., \\<median change, \\>median change in size on CT, computed by subtracting the baseline value from the value at the appropriate follow-up point).'}, {'measure': 'Evaluate the Ability of Fludeoxyglucose (18F) Positron-Emission Tomography (FDG-PET) to Monitor Response Following Radiofrequency Ablation (RFA)', 'timeFrame': 'Baseline, 6 weeks, 3 months, and 6 months following treatment', 'description': 'PET scan images was to be read by a physician experienced in the interpretation of whole body PET imaging. The region of interest was to be performed in any abnormal sites of uptake that is a candidate and or has been RFA ablated.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['localized unresectable adult primary liver cancer', 'recurrent adult primary liver cancer', 'liver metastases', 'unspecified adult solid tumor, protocol specific'], 'conditions': ['Liver Cancer', 'Metastatic Cancer', 'Unspecified Adult Solid Tumor, Protocol Specific']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Radiofrequency ablation is a procedure that heats tumors to several degrees above body temperature and may kill tumor cells.\n\nPURPOSE: Phase II trial to study the effectiveness of radiofrequency ablation in treating patients who have unresectable primary or metastatic liver cancer.', 'detailedDescription': 'OBJECTIVES:\n\n* Evaluate the nature and duration of response of patients with primary or metastatic liver neoplasms, who are not candidates for surgical resection, treated with radiofrequency interstitial tissue ablation.\n* Evaluate the ability of dynamic magnetic resonance imaging (MRI) to assess the effects of this therapy on tumor blood flow and tumor vascular density in these patients.\n* Determine the ability of positron emission tomography with fludeoxyglucose F 18 (FDG-PET) to monitor response after treatment with this therapy in these patients.\n* Compare FDG-PET results with computed tomography (CT) scan, biopsy, and serum marker results in patients treated with this therapy.\n* Compare the performance of FDG-PET with CT scan and MRI, in terms of their ability to assess the efficacy of this therapy in these patients.\n\nOUTLINE: Lesions are targeted by ultrasound and then radiofrequency ablation needles are inserted into the lesions and heated to a target temperature greater than 60 degrees C for 15 minutes, though exposure time may vary depending on temperatures achieved. To achieve a 1 cm margin of ablated tissue around each lesion, multiple ablation courses may be performed, depending on the size of the lesions and the time required to complete the treatment.\n\nPatients undergo magnetic resonance imaging with gadopentetate dimeglumine contrast, CT scan, ultrasound, and positron emission tomography with fludeoxyglucose F 18 at baseline, 6 weeks, every 3 months for 1 year, and then every 6 months for 2 years.\n\nPatients are followed at 6 weeks, every 3 months for 1 year, and then every 6 months for 2 years or until evidence of recurrence.\n\nPROJECTED ACCRUAL: A total of 58 patients will be accrued for this study within 6 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically confirmed primary or metastatic liver lesions\n\n * Not a candidate for surgical resection\n* Must have six or fewer lesions and no single lesion greater than 7 cm in diameter\n* Extrahepatic disease allowed\n\nPATIENT CHARACTERISTICS:\n\nAge:\n\n* 18 and over\n\nPerformance status:\n\n* Eastern Cooperative Oncology Group (ECOG) 0-2\n\nLife expectancy:\n\n* At least 3 months\n\nHematopoietic:\n\n* Platelet count at least 50,000/mm\\^3\n* Prothrombin time (PT) or partial thromboplastin time (PTT) no greater than 1.5 times control (except for therapeutically anticoagulated nonrelated medical conditions \\[e.g., atrial fibrillation\\])\n\nHepatic:\n\n* Bilirubin no greater than 3.0 mg/dL\n\nRenal:\n\n* Creatinine no greater than 2.5 mg/dL\n\nOther:\n\n* Not pregnant or nursing\n* Negative pregnancy test\n* No pacemakers, cerebral aneurysm clips, shrapnel injury, or implantable electronic devices\n* No known uncontrollable serious reactions (e.g., anaphylaxis) to contrast agents used in this study\n* Weight less than 136 kg\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy:\n\n* Not specified\n\nChemotherapy:\n\n* Not specified\n\nEndocrine therapy:\n\n* Not specified\n\nRadiotherapy:\n\n* Not specified\n\nSurgery:\n\n* Not specified\n\nOther:\n\n* Concurrent systemic therapy for extrahepatic disease is allowed only if begun prior to radiofrequency ablation'}, 'identificationModule': {'nctId': 'NCT00019604', 'briefTitle': 'Radiofrequency Ablation in Treating Patients With Unresectable Primary or Metastatic Liver Cancer', 'nctIdAliases': ['NCT00001795'], 'organization': {'class': 'NIH', 'fullName': 'National Institutes of Health Clinical Center (CC)'}, 'officialTitle': 'The Use of Radiofrequency Ablation to Treat Hepatic Neoplasms', 'orgStudyIdInfo': {'id': '990025'}, 'secondaryIdInfos': [{'id': '99-C-0025'}, {'id': 'CDR0000066875'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Radiofrequency ablation in liver cancer', 'description': 'This trial is designed to gain experience with the use of ablation devices with liver tumors. Radiofrequency ablation is a procedure that heats tumors to several degrees above body temperature and may kill tumor cells.', 'interventionNames': ['Procedure: computed tomography', 'Procedure: magnetic resonance imaging', 'Procedure: positron emission tomography', 'Procedure: radiofrequency ablation', 'Procedure: radionuclide imaging', 'Procedure: ultrasound imaging', 'Radiation: fludeoxyglucose F 18 (FDG-PET)', 'Radiation: gadopentetate dimeglumine']}], 'interventions': [{'name': 'computed tomography', 'type': 'PROCEDURE', 'description': 'Scan to assess the effects of ablation.', 'armGroupLabels': ['Radiofrequency ablation in liver cancer']}, {'name': 'magnetic resonance imaging', 'type': 'PROCEDURE', 'description': 'Imaging used to assess the effects of this ablative therapy on tumor vascular density.', 'armGroupLabels': ['Radiofrequency ablation in liver cancer']}, {'name': 'positron emission tomography', 'type': 'PROCEDURE', 'description': 'Physiology based method of imaging disease based on uptake and metabolism of radiopharmaceutical by the tissues.', 'armGroupLabels': ['Radiofrequency ablation in liver cancer']}, {'name': 'radiofrequency ablation', 'type': 'PROCEDURE', 'description': 'Radiofrequency ablation uses saline infusion into and out of needle/electrode through a closed system. More energy may be deposited without tissue-charring or gas vaporization.', 'armGroupLabels': ['Radiofrequency ablation in liver cancer']}, {'name': 'radionuclide imaging', 'type': 'PROCEDURE', 'description': 'Imaging following injection of a radioactive material.', 'armGroupLabels': ['Radiofrequency ablation in liver cancer']}, {'name': 'ultrasound imaging', 'type': 'PROCEDURE', 'description': 'An ultrasound (e.g. sound waves) is used to identify the lesion and needle placement.', 'armGroupLabels': ['Radiofrequency ablation in liver cancer']}, {'name': 'fludeoxyglucose F 18 (FDG-PET)', 'type': 'RADIATION', 'description': 'FDG PET scans rely on metabolic changes to evaluate response to therapy.', 'armGroupLabels': ['Radiofrequency ablation in liver cancer']}, {'name': 'gadopentetate dimeglumine', 'type': 'RADIATION', 'description': 'Food and Drug Administration approved contrast agent.', 'armGroupLabels': ['Radiofrequency ablation in liver cancer']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20892-1182', 'city': 'Bethesda', 'state': 'Maryland', 'country': 'United States', 'facility': 'Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office', 'geoPoint': {'lat': 38.98067, 'lon': -77.10026}}], 'overallOfficials': [{'name': 'Steven A Libutti, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Cancer Institute, National Institutes of Health'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Institutes of Health Clinical Center (CC)', 'class': 'NIH'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Caryn Steakley, R.N.', 'investigatorAffiliation': 'National Institutes of Health Clinical Center (CC)'}}}}