The Clinical Validity and Safety of IOP Injection MRI Contrast Agent in Hepatocellular Carcinoma

Study Overview
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Brief Summary
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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
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The planned duration of the clinical study for individual subjects is up to 12 weeks.

Official Title
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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)

Conditions
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Magnetic Resonance Imaging

Intervention / Treatment
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* Drug: IOP Injection (MPB-1523)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: single arm: IOP injection (MPB-1523)<br>single group treatment | Drug: IOP Injection (MPB-1523)<br>* one dose, once IV injection at Day 1<br>* Other names: MRI Contrast Agent;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | After IOP injection administration within 60 mins | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Optimal time to perform a MRI scan after injection of IOP | Optimal time of IOP Injection | After IOP injection administration within 60 mins | 
| The Number of lesions detected in liver | The sensitivity of IOP Injection | After IOP injection administration within 60 mins | 
| The size of lesions detected in liver | The sensitivity of IOP Injection | After IOP injection administration within 60 mins | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hepatocellular Carcinoma, Magnetic Resonance Imaging