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

Phase 2

Completed

• Conditions: Magnetic Resonance Imaging
• Interventions: Drug: IOP Injection (MPB-1523)

• Registration Number: NCT03407495
• Lead Sponsor: MegaPro Biomedical Co. Ltd.

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.

Study Timeline

• Study First Submitted: 2018-01-15
• Study First Submitted QC: 2018-01-22
• Study First Posted: 2018-01-23
• Study Start: 2018-11-22
• Primary Completion: 2020-08-30
• Study Completion: 2020-10-30
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-21
• Last Update Posted: 2021-10-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

Inclusion Criteria

1. Subjects ≥18 years of age
2. Patients with suspected HCC scheduled for partial hepatic resection.
3. 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.
4. 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

1. Subjects who received any previous treatment for HCC.
2. Subjects with a serious allergic history or known allergy of other contrast agent.
3. Subjects with a positive HIV test.
4. Subjects with severe renal insufficiency
5. Subjects with severe liver disease[HCV].
6. 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.
7. Subject with mechanically, electrically or magnetically-activated implanted device or any metal in their body which cannot be removed.
8. Subjects who have participated in other investigational trials within 30 days prior to study enrollment.
9. Female subjects who are pregnant or breastfeeding.
10. Subjects who are clinically unstable and whose clinical course during the screening period is unpredictable.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
single arm: IOP injection (MPB-1523)	IOP Injection (MPB-1523)	single group treatment

Primary Outcome Measures

Name	Time	Method
The Sensitivity and specificity of IOP-enhanced MRI	After IOP injection administration within 60 mins	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.

Secondary Outcome Measures

Name	Time	Method
The Number of lesions detected in liver	After IOP injection administration within 60 mins	The sensitivity of IOP Injection
Optimal time to perform a MRI scan after injection of IOP	After IOP injection administration within 60 mins	Optimal time of IOP Injection
The size of lesions detected in liver	After IOP injection administration within 60 mins	The sensitivity of IOP Injection

Trial Locations

Locations (5)

China Medical University Hospital; 🇨🇳 Taichung, Taiwan

National Cheng Kung University Hospital; 🇨🇳 Tainan, Taiwan

Taichung Veterans General Hospital; 🇨🇳 Taichung, Taiwan

Chang Gung Medical Foundation; 🇨🇳 Kaohsiung, Taiwan

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan