Ignite Creation Date:
2025-12-24 @ 2:08 PM
Ignite Modification Date:
2025-12-27 @ 9:24 PM
Study NCT ID:
NCT03407495
Status:
COMPLETED
Last Update Posted:
2021-10-22
First Post:
2018-01-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Clinical Validity and Safety of IOP Injection MRI Contrast Agent in Hepatocellular Carcinoma
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': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 52}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-11-22', 'type': 'ACTUAL'}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2020-10-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-10-21', 'studyFirstSubmitDate': '2018-01-15', 'studyFirstSubmitQcDate': '2018-01-22', 'lastUpdatePostDateStruct': {'date': '2021-10-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-01-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-08-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Sensitivity and specificity of IOP-enhanced MRI', 'timeFrame': 'After IOP injection administration within 60 mins', 'description': 'Sensitivity and specificity of IOP-enhanced MRI will be calculated using dynamic multiphase MDCT as the reference standard. Confirmation of the diagnosis of HCC lesions will be obtained by surgery.'}], 'secondaryOutcomes': [{'measure': 'Optimal time to perform a MRI scan after injection of IOP', 'timeFrame': 'After IOP injection administration within 60 mins', 'description': 'Optimal time of IOP Injection'}, {'measure': 'The Number of lesions detected in liver', 'timeFrame': 'After IOP injection administration within 60 mins', 'description': 'The sensitivity of IOP Injection'}, {'measure': 'The size of lesions detected in liver', 'timeFrame': 'After IOP injection administration within 60 mins', 'description': 'The sensitivity of IOP Injection'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hepatocellular Carcinoma', 'Magnetic Resonance Imaging'], 'conditions': ['Magnetic Resonance Imaging']}, 'descriptionModule': {'briefSummary': 'This study is an exploratory study aiming to collect data on sensitivity and positive predictive value of IOP-enhanced (MPB-1523) MRI compared to dynamic multiphase MDCT for the detection of HCC.', 'detailedDescription': 'The planned duration of the clinical study for individual subjects is up to 12 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Subjects ≥18 years of age\n2. Patients with suspected HCC scheduled for partial hepatic resection.\n3. Presenting with 1 to a maximum of 5 hepatic nodule(s) of equal or more than 1 cm (long axis) previously identified and characterized through multi-phase contrast enhanced CT.\n4. Subjects or their partners must use a highly effective method of contraception starting from at least one menstrual cycle prior to starting study drug and till 30 days after the last dose of study drug.\n\nExclusion Criteria:\n\n1. Subjects who received any previous treatment for HCC.\n2. Subjects with a serious allergic history or known allergy of other contrast agent.\n3. Subjects with a positive HIV test.\n4. Subjects with severe renal insufficiency\n5. Subjects with severe liver disease\\[HCV\\].\n6. Subjects with active systemic infections, active and clinically significant cardiac diseases, active gastrointestinal ulcers, or medical conditions that may significantly affect action, adequate absorption, and elimination of investigational contrast agent.\n7. Subject with mechanically, electrically or magnetically-activated implanted device or any metal in their body which cannot be removed.\n8. Subjects who have participated in other investigational trials within 30 days prior to study enrollment.\n9. Female subjects who are pregnant or breastfeeding.\n10. Subjects who are clinically unstable and whose clinical course during the screening period is unpredictable.'}, 'identificationModule': {'nctId': 'NCT03407495', 'briefTitle': 'The Clinical Validity and Safety of IOP Injection MRI Contrast Agent in Hepatocellular Carcinoma', 'organization': {'class': 'INDUSTRY', 'fullName': 'MegaPro Biomedical Co. Ltd.'}, 'officialTitle': 'A Phase II, Multi-Center, Open-Label, Single-Arm Study to Evaluate the Clinical Validity and Safety of IOP Injection for Magnetic Resonance Imaging (MRI) Contrast Agent in Hepatocellular Carcinoma (HCC)', 'orgStudyIdInfo': {'id': 'IOP-CT-003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'single arm: IOP injection (MPB-1523)', 'description': 'single group treatment', 'interventionNames': ['Drug: IOP Injection (MPB-1523)']}], 'interventions': [{'name': 'IOP Injection (MPB-1523)', 'type': 'DRUG', 'otherNames': ['MRI Contrast Agent'], 'description': 'one dose, once IV injection at Day 1', 'armGroupLabels': ['single arm: IOP injection (MPB-1523)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '833', 'city': 'Kaohsiung City', 'country': 'Taiwan', 'facility': 'Chang Gung Medical Foundation', 'geoPoint': {'lat': 22.61626, 'lon': 120.31333}}, {'zip': '404', 'city': 'Taichung', 'country': 'Taiwan', 'facility': 'China Medical University Hospital', 'geoPoint': {'lat': 24.1469, 'lon': 120.6839}}, {'zip': '407', 'city': 'Taichung', 'country': 'Taiwan', 'facility': 'Taichung Veterans General Hospital', 'geoPoint': {'lat': 24.1469, 'lon': 120.6839}}, {'zip': '704', 'city': 'Tainan', 'country': 'Taiwan', 'facility': 'National Cheng Kung University Hospital', 'geoPoint': {'lat': 22.99083, 'lon': 120.21333}}, {'zip': '100', 'city': 'Taipei', 'country': 'Taiwan', 'facility': 'National Taiwan University Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'overallOfficials': [{'name': 'Chien-Hung Chen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Taiwan University Hospital'}, {'name': 'David Wang, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'MegaPro Biomedical Co. Ltd.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'MegaPro Biomedical Co. Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}