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)

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.

Study Overview

• Status: Completed
• Conditions: Magnetic Resonance Imaging
• Intervention / Treatment: Drug: IOP Injection (MPB-1523)

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Phase 2

Contacts and Locations

Study Locations

• Taiwan
  • Kaohsiung, Taiwan, 833
    • Chang Gung Medical Foundation
  • Taichung, Taiwan, 404
    • China Medical University Hospital
  • Taichung, Taiwan, 407
    • Taichung Veterans General Hospital
  • Tainan, Taiwan, 704
    • National Cheng Kung University Hospital
  • Taipei, Taiwan, 100
    • National Taiwan University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: single arm: IOP injection (MPB-1523); single group treatment	Drug: IOP Injection (MPB-1523); one dose, once IV injection at Day 1; Other Names: MRI Contrast Agent

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: MegaPro Biomedical Co. Ltd.
• Investigators: Study Director: David Wang, MD, MegaPro Biomedical Co. Ltd.

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 22, 2018
• Primary Completion (ACTUAL): August 30, 2020
• Study Completion (ACTUAL): October 30, 2020

Study Registration Dates

• First Submitted: January 15, 2018
• First Submitted That Met QC Criteria: January 22, 2018
• First Posted (ACTUAL): January 23, 2018

Study Record Updates

• Last Update Posted (ACTUAL): October 22, 2021
• Last Update Submitted That Met QC Criteria: October 21, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: Hepatocellular Carcinoma; Magnetic Resonance Imaging
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Neoplasms, Glandular and Epithelial; Digestive System Neoplasms; Liver Diseases; Liver Neoplasms; Carcinoma; Carcinoma, Hepatocellular
• Other Study ID Numbers: IOP-CT-003

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No