A Phase 2 interventional study of IOP Injection (MPB-1523) in Magnetic Resonance Imaging, sponsored by MegaPro Biomedical Co. Ltd.. Completed at 5 sites in Taiwan. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-10-22.
Sponsored by MegaPro Biomedical Co. Ltd. · Phase 2, Interventional, and Diagnostic
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.
The planned duration of the clinical study for individual subjects is up to 12 weeks.
Exclusion Criteria:
single group treatment
Drug: IOP Injection (MPB-1523)
one dose, once IV injection at Day 1
Also known as: MRI Contrast Agent
The Sensitivity and specificity of IOP-enhanced MRI
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.
Time frame: After IOP injection administration within 60 mins
Optimal time to perform a MRI scan after injection of IOP
Optimal time of IOP Injection
Time frame: After IOP injection administration within 60 mins
The Number of lesions detected in liver
The sensitivity of IOP Injection
Time frame: After IOP injection administration within 60 mins
The size of lesions detected in liver
The sensitivity of IOP Injection
Time frame: After IOP injection administration within 60 mins
This study is completed, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.
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MegaPro Biomedical Co. Ltd.