Trials / Completed
CompletedNCT03407495
The Clinical Validity and Safety of IOP Injection MRI Contrast Agent in Hepatocellular Carcinoma
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)
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 52 (actual)
- Sponsor
- MegaPro Biomedical Co. Ltd. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | IOP Injection (MPB-1523) | one dose, once IV injection at Day 1 |
Timeline
- Start date
- 2018-11-22
- Primary completion
- 2020-08-30
- Completion
- 2020-10-30
- First posted
- 2018-01-23
- Last updated
- 2021-10-22
Locations
5 sites across 1 country: Taiwan
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03407495. Inclusion in this directory is not an endorsement.