Ignite Creation Date:
2025-12-25 @ 12:14 AM
Ignite Modification Date:
2025-12-25 @ 10:16 PM
Study NCT ID:
NCT00162058
Status:
COMPLETED
Last Update Posted:
2011-08-18
First Post:
2005-09-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Phase II Study of DMP 115 to Assess Focal Liver Lesions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008107', 'term': 'Liver Diseases'}], 'ancestors': [{'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-08', 'completionDateStruct': {'date': '2006-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-08-17', 'studyFirstSubmitDate': '2005-09-09', 'studyFirstSubmitQcDate': '2005-09-09', 'lastUpdatePostDateStruct': {'date': '2011-08-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The ratio of signal intensities obtained from unenhanced vs. contrast-enhanced ultrasound imaging of liver tissue and liver lesions will be calculated at the end of the study.'}], 'secondaryOutcomes': [{'measure': 'The determination of the presence or absence of focal liver lesions during the Blinded Read and the Institutional Read of ultrasound images.'}]}, 'conditionsModule': {'conditions': ['Liver Disease']}, 'descriptionModule': {'briefSummary': 'To determine the optimal dose of DMP 115 to image liver lesions and to assess whether contrast can improve the detection of focal liver lesions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosed with 1 but \\<7 focal liver lesions\n* Scheduled for liver biopsy within 30 days of study\n* Scheduled for CT or MR within 30 days of study\n\nExclusion Criteria:\n\n* Critically ill subjects\n* Subjects with right-to-left shunts'}, 'identificationModule': {'nctId': 'NCT00162058', 'briefTitle': 'A Phase II Study of DMP 115 to Assess Focal Liver Lesions', 'organization': {'class': 'INDUSTRY', 'fullName': 'Lantheus Medical Imaging'}, 'officialTitle': 'An Open-Label, Non-Randomized, Phase II Trial To Assess Focal Liver Lesion Detection Using Definity-Enhanced Ultrasound Imaging', 'orgStudyIdInfo': {'id': 'DMP 115-214'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Peflutren Lipid Microsphere Injectable Suspension', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Glasgow', 'state': 'Scotland', 'country': 'United Kingdom', 'facility': 'Local Institution', 'geoPoint': {'lat': 55.86515, 'lon': -4.25763}}], 'overallOfficials': [{'name': 'Edward L.S. Leen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Consultant Radiologist, Royal Infirmary'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lantheus Medical Imaging', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Qi Zhu, MD Sr. Medical Director', 'oldOrganization': 'Lantheus Medical Imaging'}}}}