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CompletedNCT03407495Updated Oct 22, 2021

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

A Phase 2 interventional study of IOP Injection (MPB-1523) in Magnetic Resonance Imaging, sponsored by MegaPro Biomedical Co. Ltd.. Completed at 5 sites in Taiwan. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-10-22.

Sponsored by MegaPro Biomedical Co. Ltd. · Phase 2, Interventional, and Diagnostic

Phase
Phase 2
Study type
Interventional
Enrollment
52
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

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

02

Conditions studied

  • Magnetic Resonance Imaging

Keywords

  • Hepatocellular Carcinoma
  • Magnetic Resonance Imaging
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
04

Study design

Phase
Phase 2
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
52 participants (actual)

Study arms

  • Experimental
    single arm: IOP injection (MPB-1523)

    single group treatment

    Drug: IOP Injection (MPB-1523)

Interventions

  • DrugIOP Injection (MPB-1523)

    one dose, once IV injection at Day 1

    Also known as: MRI Contrast Agent

05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: After IOP injection administration within 60 mins

Secondary outcomes

  1. Optimal time to perform a MRI scan after injection of IOP

    Optimal time of IOP Injection

    Time frame: After IOP injection administration within 60 mins

  2. The Number of lesions detected in liver

    The sensitivity of IOP Injection

    Time frame: After IOP injection administration within 60 mins

  3. The size of lesions detected in liver

    The sensitivity of IOP Injection

    Time frame: After IOP injection administration within 60 mins

06

Study locations

5 sites
  • Chang Gung Medical Foundation
    Kaohsiung, 833, Taiwan
  • China Medical University Hospital
    Taichung, 404, Taiwan
  • Taichung Veterans General Hospital
    Taichung, 407, Taiwan
  • National Cheng Kung University Hospital
    Tainan, 704, Taiwan
  • National Taiwan University Hospital
    Taipei, 100, Taiwan
07

Registry details

Key details

Study ID
NCT03407495
Lead sponsor
MegaPro Biomedical Co. Ltd.
Responsible party
Sponsor
First posted
Jan 23, 2018
Start date
Nov 22, 2018
Primary completion
Aug 30, 2020
Completion
Oct 30, 2020
Last update
Oct 22, 2021

Study contacts

Chien-Hung Chen, MD
principal investigator · National Taiwan University Hospital
David Wang, MD
study director · MegaPro Biomedical Co. Ltd.

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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