Status:
COMPLETED
The Clinical Validity and Safety of IOP Injection MRI Contrast Agent in Hepatocellular Carcinoma
Lead Sponsor:
MegaPro Biomedical Co. Ltd.
Conditions:
Magnetic Resonance Imaging
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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.
Detailed Description
The planned duration of the clinical study for individual subjects is up to 12 weeks.
Eligibility Criteria
Inclusion
- Subjects ≥18 years of age
- Patients with suspected HCC scheduled for partial hepatic resection.
- 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.
- 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
- Subjects who received any previous treatment for HCC.
- Subjects with a serious allergic history or known allergy of other contrast agent.
- Subjects with a positive HIV test.
- Subjects with severe renal insufficiency
- Subjects with severe liver disease\[HCV\].
- 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.
- Subject with mechanically, electrically or magnetically-activated implanted device or any metal in their body which cannot be removed.
- Subjects who have participated in other investigational trials within 30 days prior to study enrollment.
- Female subjects who are pregnant or breastfeeding.
- Subjects who are clinically unstable and whose clinical course during the screening period is unpredictable.
Key Trial Info
Start Date :
November 22 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 30 2020
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT03407495
Start Date
November 22 2018
End Date
October 30 2020
Last Update
October 22 2021
Active Locations (5)
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1
Chang Gung Medical Foundation
Kaohsiung City, Taiwan, 833
2
China Medical University Hospital
Taichung, Taiwan, 404
3
Taichung Veterans General Hospital
Taichung, Taiwan, 407
4
National Cheng Kung University Hospital
Tainan, Taiwan, 704