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

Magnetic Resonance Imaging Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03407495
• Other study ID #: IOP-CT-003
• Status: Completed
• Phase: Phase 2
• Start date: November 22, 2018
• Est. completion date: October 30, 2020

Study information

• Verified date: October 2021
• Source: MegaPro Biomedical Co. Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: October 30, 2020
• Est. primary completion date: August 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Magnetic Resonance Imaging

Intervention

Drug:
• IOP Injection (MPB-1523)
one dose, once IV injection at Day 1

Locations

Country	Name	City	State
Taiwan	Chang Gung Medical Foundation	Kaohsiung
Taiwan	China Medical University Hospital	Taichung
Taiwan	Taichung Veterans General Hospital	Taichung
Taiwan	National Cheng Kung University Hospital	Tainan
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
MegaPro Biomedical Co. Ltd.

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Optimal time to perform a MRI scan after injection of IOP	Optimal time of IOP Injection	After IOP injection administration within 60 mins
Secondary	The Number of lesions detected in liver	The sensitivity of IOP Injection	After IOP injection administration within 60 mins
Secondary	The size of lesions detected in liver	The sensitivity of IOP Injection	After IOP injection administration within 60 mins