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

Primary Purpose

Magnetic Resonance Imaging

Status

Completed

Phase

Phase 2

Locations

Taiwan

Study Type

Interventional

Intervention

IOP Injection (MPB-1523)

About this trial

This is an interventional diagnostic trial for Magnetic Resonance Imaging focused on measuring Hepatocellular Carcinoma, Magnetic Resonance Imaging

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Chang Gung Medical Foundation
China Medical University Hospital
Taichung Veterans General Hospital
National Cheng Kung University Hospital
National Taiwan University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

single arm: IOP injection (MPB-1523)

Arm Description

single group treatment

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Optimal time to perform a MRI scan after injection of IOP

Optimal time of IOP Injection

The Number of lesions detected in liver

The sensitivity of IOP Injection

The size of lesions detected in liver

The sensitivity of IOP Injection

Full Information

NCT ID

NCT03407495

First Posted

January 15, 2018

Last Updated

October 21, 2021

Sponsor

MegaPro Biomedical Co. Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT03407495

Brief Title

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

Official Title

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)

Study Type

Interventional

2. Study Status

Record Verification Date

October 2021

Overall Recruitment Status

Completed

Study Start Date

November 22, 2018 (Actual)

Primary Completion Date

August 30, 2020 (Actual)

Study Completion Date

October 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

MegaPro Biomedical Co. Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Magnetic Resonance Imaging

Keywords

Hepatocellular Carcinoma, Magnetic Resonance Imaging

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

52 (Actual)

8. Arms, Groups, and Interventions

Arm Title

single arm: IOP injection (MPB-1523)

Arm Type

Experimental

Arm Description

single group treatment

Intervention Type

Drug

Intervention Name(s)

IOP Injection (MPB-1523)

Other Intervention Name(s)

MRI Contrast Agent

Intervention Description

one dose, once IV injection at Day 1

Primary Outcome Measure Information:

Title

The Sensitivity and specificity of IOP-enhanced MRI

Description

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

Secondary Outcome Measure Information:

Title

Optimal time to perform a MRI scan after injection of IOP

Description

Optimal time of IOP Injection

Time Frame

After IOP injection administration within 60 mins

Title

The Number of lesions detected in liver

Description

The sensitivity of IOP Injection

Time Frame

After IOP injection administration within 60 mins

Title

The size of lesions detected in liver

Description

The sensitivity of IOP Injection

Time Frame

After IOP injection administration within 60 mins

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Chien-Hung Chen, MD

Organizational Affiliation

National Taiwan University Hospital

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

David Wang, MD

Organizational Affiliation

MegaPro Biomedical Co. Ltd.

Official's Role

Study Director

Facility Information:

Facility Name

Chang Gung Medical Foundation

City

Kaohsiung

ZIP/Postal Code

833

Country

Taiwan

Facility Name

China Medical University Hospital

City

Taichung

ZIP/Postal Code

404

Country

Taiwan

Facility Name

Taichung Veterans General Hospital

City

Taichung

ZIP/Postal Code

407

Country

Taiwan

Facility Name

National Cheng Kung University Hospital

City

Tainan

ZIP/Postal Code

704

Country

Taiwan

Facility Name

National Taiwan University Hospital

City

Taipei

ZIP/Postal Code

100

Country

Taiwan

12. IPD Sharing Statement

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

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