The Clinical Validity and Safety of IOP Injection MRI Contrast Agent in Hepatocellular Carcinoma
NCT ID: NCT03407495
Last Updated: 2021-10-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
52 participants
INTERVENTIONAL
2018-11-22
2020-10-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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single arm: IOP injection (MPB-1523)
single group treatment
IOP Injection (MPB-1523)
one dose, once IV injection at Day 1
Interventions
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IOP Injection (MPB-1523)
one dose, once IV injection at Day 1
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Patients with suspected HCC scheduled for partial hepatic resection.
3. 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.
4. 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.
Exclusion Criteria
2. Subjects with a serious allergic history or known allergy of other contrast agent.
3. Subjects with a positive HIV test.
4. Subjects with severe renal insufficiency
5. Subjects with severe liver disease\[HCV\].
6. 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.
7. Subject with mechanically, electrically or magnetically-activated implanted device or any metal in their body which cannot be removed.
8. Subjects who have participated in other investigational trials within 30 days prior to study enrollment.
9. Female subjects who are pregnant or breastfeeding.
10. Subjects who are clinically unstable and whose clinical course during the screening period is unpredictable.
18 Years
ALL
No
Sponsors
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MegaPro Biomedical Co. Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Chien-Hung Chen, MD
Role: PRINCIPAL_INVESTIGATOR
National Taiwan University Hospital
David Wang, MD
Role: STUDY_DIRECTOR
MegaPro Biomedical Co. Ltd.
Locations
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Chang Gung Medical Foundation
Kaohsiung City, , Taiwan
China Medical University Hospital
Taichung, , Taiwan
Taichung Veterans General Hospital
Taichung, , Taiwan
National Cheng Kung University Hospital
Tainan City, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Countries
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Other Identifiers
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IOP-CT-003
Identifier Type: -
Identifier Source: org_study_id