Ignite Creation Date:
2025-12-25 @ 3:38 AM
Ignite Modification Date:
2026-06-28 @ 8:12 PM
Study NCT ID:
NCT00584402
Status:
COMPLETED
Last Update Posted:
2017-07-11
First Post:
2007-12-21
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Contrast Sonography for Evaluation of Liver Tumors Prior to Radiofrequency Ablation
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008113', 'term': 'Liver Neoplasms'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C042852', 'term': 'perflutren'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'john.mcgahan@ucdmc.ucdavis.edu', 'phone': '(916)734-0519', 'title': 'John McGahan, M.D.', 'organization': 'University of Califonia, Davis'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '15 min post injection', 'description': 'All-cause mortality and other (not including serious) adverse events were not collected/assessed', 'eventGroups': [{'id': 'EG000', 'title': 'Contrast Sonography', 'description': 'Contrast-enhanced sonography\n\nperflutren lipid microspheres : IV in 0.1 cc doses, as needed, to enhance lesion conspicuity', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 8, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percent of Tumors With Increased Echogenicity (Brightness) Following Contrast-enhanced Sonography', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}, {'units': 'tumor', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Contrast Sonography', 'description': 'Subjects undergoing contrast sonography'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': '15 min', 'description': 'After the systemic iv injection of ultrasound contrast, the real time ultrasound images are visually evaluated, and small intrahepatic tumors are detected on the images. The images pre-contrast and post contrast are compared visually. One tumor per participant was analyzed.', 'unitOfMeasure': 'tumor', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'tumor', 'denomUnitsSelected': 'tumor', 'populationDescription': 'Tumors were evaluated prior and post contrast injection, 1 tumor per participant'}, {'type': 'SECONDARY', 'title': 'Number of Participants With an Increase in Echogenicity (Brightness) of Small Intrahepatic Tumors Following Contrast-enhanced Sonography Based on Tumor Type, Size, Location and Depth', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Contrast Sonography', 'description': 'Subjects undergoing contrast sonography'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '15 min', 'description': 'Visual estimation of the the effect of tumor type, size, location and depth on the conspicuity of small tumors on contrast-enhanced sonography using prior assessment or pathology for tumor type', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Tumor types showed differences in enhancement'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Contrast Sonography', 'description': 'Contrast-enhanced sonography\n\nperflutren lipid microspheres : IV in 0.1 cc doses, as needed, to enhance lesion conspicuity'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Closed to enrollment', 'preAssignmentDetails': 'Closed to enrollment'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Contrast Sonography', 'description': 'Contrast-enhanced sonography perflutren lipid microspheres : IV in 0.1 cc doses, as needed, to enhance lesion conspicuity'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Male', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}, {'title': 'Female', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'completionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-07-10', 'studyFirstSubmitDate': '2007-12-21', 'resultsFirstSubmitDate': '2013-07-03', 'studyFirstSubmitQcDate': '2007-12-21', 'lastUpdatePostDateStruct': {'date': '2017-07-11', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-07-10', 'studyFirstPostDateStruct': {'date': '2008-01-02', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-07-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent of Tumors With Increased Echogenicity (Brightness) Following Contrast-enhanced Sonography', 'timeFrame': '15 min', 'description': 'After the systemic iv injection of ultrasound contrast, the real time ultrasound images are visually evaluated, and small intrahepatic tumors are detected on the images. The images pre-contrast and post contrast are compared visually. One tumor per participant was analyzed.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With an Increase in Echogenicity (Brightness) of Small Intrahepatic Tumors Following Contrast-enhanced Sonography Based on Tumor Type, Size, Location and Depth', 'timeFrame': '15 min', 'description': 'Visual estimation of the the effect of tumor type, size, location and depth on the conspicuity of small tumors on contrast-enhanced sonography using prior assessment or pathology for tumor type'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['liver cancer'], 'conditions': ['Liver Neoplasms']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the efficacy of the Definity (perflutren lipid microsphere Injectable Suspension) ultrasound contrast agent in identifying small tumors (hepatomas \\& metastases) within the liver.\n\nPrimary objective: To estimate the increase in conspicuity of small intrahepatic tumors with contrast-enhanced sonography\n\nSecondary Objectives: To estimate the effect of tumor type, size, location and depth on the conspicuity of small tumors on contrast-enhanced sonography', 'detailedDescription': 'An estimated 75 patients (age 18 years of age or older) will be enrolled from the population of patients who present for ultrasound-guided radiofrequency ablation (RFA) of CT or MRI-confirmed multiple primary hepatocellular carcinoma (HCC) or metastatic carcinoma, with at least one of the tumors being ≤ 1.5 cm in diameter.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with primary hepatocellular carcinoma (HCC) or secondary (metastatic) carcinoma of the liver who have been referred for ultrasound-guided radiofrequency ablation (RFA) treatment\n* Recent (within 90 days) CT or MRI scan with report of one or more tumors ≤ 1.5 cm in diameter\n* Patient is stable and is to be managed conservatively (i.e. non-surgically)\n* 18 years of age or older\n* Ability and willingness to provide written informed consent\n\nExclusion Criteria:\n\n* Known or suspected cardiac shunt(s)\n* Known sensitivity to octafluoropropane\n* Pregnant or breastfeeding'}, 'identificationModule': {'nctId': 'NCT00584402', 'briefTitle': 'Contrast Sonography for Evaluation of Liver Tumors Prior to Radiofrequency Ablation', 'organization': {'class': 'OTHER', 'fullName': 'University of California, Davis'}, 'officialTitle': 'Contrast Sonography for Evaluation of Liver Tumors Prior to Radiofrequency Ablation', 'orgStudyIdInfo': {'id': '200715241'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Contrast sonography', 'description': 'Contrast-enhanced sonography perflutren lipid microspheres', 'interventionNames': ['Drug: perflutren lipid microspheres']}], 'interventions': [{'name': 'perflutren lipid microspheres', 'type': 'DRUG', 'otherNames': ['Definity'], 'description': 'perflutren lipid microspheres IV in 0.1 cc doses, as needed, to enhance lesion conspicuity', 'armGroupLabels': ['Contrast sonography']}]}, 'contactsLocationsModule': {'locations': [{'zip': '95817', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'UC Davis Medical Center', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}], 'overallOfficials': [{'name': 'John P. McGahan, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UC Davis School of Medicine Dept. of Radiology'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, Davis', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}