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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

From the registry’s dates

  • Primary completion was Aug 2020, 6 years 2 months ago, and no results have been posted to the registry.
Phase
Phase 2
Study type
Interventional
Enrollment
52
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 273 studies in Carcinoma, Hepatocellular with a site in Taiwan — 46 open to participants now, 69 under way, 11 of them phase 3. Carcinoma, Hepatocellular · Taiwan.

Enrollment
145th of 224
52 · median 98
Started
2018
with 12 others
Phase 2
70 of 273
14 open now
Registered
164th of 273
by date

Among the 273 studies in Carcinoma, Hepatocellular with a site in Taiwan, this one is the 145th largest by enrollment of the 224 interventional ones, is one of 13 that started in 2018, is one of 70 in phase 2, and was the 164th registered.

By phase

273 studies; the count open now beside each. This study's row is marked.

Phase 2this study70 · 14 open
Phase 349 · 2 open
Observational47 · 6 open
Phase 1/234 · 8 open
Phase 131 · 7 open
No phase26 · 6 open
Phase 413 · 3 open
Phase 2/33 · 0 open

By the year they started

First in 1997; this study’s year is marked. 13 started in 2018.

Size and results

Median enrollment 98 across the 224 interventional studies, 164 across the 47 observational. Of the 156 that completed or were terminated, 59 (38%) have results posted.

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02

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.

03

Conditions studied

  • Magnetic Resonance Imaging

Keywords

  • Hepatocellular Carcinoma
  • Magnetic Resonance Imaging
04

Who can participate

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 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 test.
  4. Subjects with severe renal insufficiency
  5. Subjects with severe liver disease[].
  6. Subjects with active systemic infections, active and cardiac diseases, active gastrointestinal ulcers, or medical conditions that may significantly affect action, adequate absorption, and elimination of 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.
Terms in these criteria, in plain language(5)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

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

06

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

07

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
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Nov 2018 to primary completion in Aug 2020, 21 months.

Of 80 industry-sponsored phase 2 interventional studies under Carcinoma, Hepatocellular, half reached primary completion within 38 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 50. This study's 21 months is below that.

Counting every sponsor, half of 428 studies reached it within 43 months; a quarter within 30 and three quarters within 71.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 15, 2018
First posted
Jan 23, 2018
StartActual
Nov 22, 2018
Primary completionActual
Aug 30, 2020
CompletionActual
Oct 30, 2020
Last update
Oct 22, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 22, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

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 ↗

Not currently enrolling

This study is completed, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.

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Discussion

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