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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
52
one dose, once IV injection at Day 1
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, Taiwan
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
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National Taiwan University Hospital
Taipei, Taiwan