Ignite Creation Date:
2025-12-24 @ 10:04 PM
Ignite Modification Date:
2025-12-29 @ 12:38 AM
Study NCT ID:
NCT00586235
Status:
COMPLETED
Last Update Posted:
2019-05-06
First Post:
2007-12-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Registration and Fusion of Real-Time Ultrasound With CT for Lesion Localization and Characterization
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-05-02', 'studyFirstSubmitDate': '2007-12-21', 'studyFirstSubmitQcDate': '2007-12-21', 'lastUpdatePostDateStruct': {'date': '2019-05-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-01-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Primary Endpoints: Global Fiducial Registration Error (FRE) of real-time US and fused CT images, Target Registration Error (TRE) and distance between lesional epicenters of real-time US and fused CT images.', 'timeFrame': '2 years'}], 'secondaryOutcomes': [{'measure': 'Secondary Endpoint: Number of coregistration attempts to realize separation of lesional epicenters of real-time US and fused CT images of ≤2 cm and the number of attempts to realize a separation of ≤0.3 cm.', 'timeFrame': '2 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Fusion', 'Ultrasound', 'Computed tomography'], 'conditions': ['Kidney or Liver Tumors']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.mayo.edu/research/clinical-trials', 'label': 'Mayo Clinic Clinical Trials'}]}, 'descriptionModule': {'briefSummary': 'Acquire CT data and US and transducer position data (magnetic sensor system) of focal hepatic or renal lesions to serve as sample data sets for fusion algorithm development and subsequent optimization.', 'detailedDescription': 'Acquire CT data and US and transducer position data (magnetic sensor system) of focal hepatic or renal lesions to serve as sample data sets for fusion algorithm development and subsequent optimization.\n\nOptimize image fusion algorithms for use in goal. Develop registration algorithms that result in maximal lesional overlap with a clinically relevant difference in an epicenter location of ≤ 2 cm for lesional identification and, ultimately ≤ 0.3 cm for interventional procedures.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with kidney or liver tumors', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Focal lesion involving the liver or kidney bases on CT or MRI Imaging\n* Liver lesion size \\>5 mm and \\<5 cm in diameter or renal lesion size is \\>5 mm and \\<4 cm in diameter\n* Age \\>18 years old\n* Patient has provided written informed consent\n\nExclusion Criteria:\n\n* Patient with cardiac pacemaker or defibrillator\n* Pregnant or lactating woman\n* Patient with severe IV contrast allergy (previous reaction to IV contrast not mitigated by appropriate premedication)\n* Patient unable to give informed consent'}, 'identificationModule': {'nctId': 'NCT00586235', 'briefTitle': 'Registration and Fusion of Real-Time Ultrasound With CT for Lesion Localization and Characterization', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Registration and Fusion of Real-Time Ultrasound With CT for Lesion Localization and Characterization', 'orgStudyIdInfo': {'id': '06-002982'}, 'secondaryIdInfos': [{'id': '06-002982'}]}, 'armsInterventionsModule': {'armGroups': [{'label': '1', 'description': 'patients with indeterminate kidney or liver lesions'}]}, 'contactsLocationsModule': {'locations': [{'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'overallOfficials': [{'name': 'Matthew R. Callstrom, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'collaborators': [{'name': 'Siemens Medical Solutions', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Study Prinicple Investigator', 'investigatorFullName': 'Matthew R. Callstrom', 'investigatorAffiliation': 'Mayo Clinic'}}}}