Magnetic Resonance ImagingPhase 2NCT03407495
The Clinical Validity and Safety of IOP Injection MRI Contrast Agent in Hepatocellular Carcinoma
A Phase 2 study testing IOP Injection (MPB-1523) in people with Magnetic Resonance Imaging, run by MegaPro Biomedical Co. Ltd. at 5 sites in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Magnetic Resonance Imaging
- What is being tested?
- IOP Injection (MPB-1523)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 5 sitesTaiwan
- Study dates
- 22 Nov 2018to 30 Oct 2020
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Taiwan5 sites
Chang Gung Medical Foundation
Kaohsiung City, 833
China Medical University Hospital
Taichung, 404
Taichung Veterans General Hospital
Taichung, 407
National Cheng Kung University Hospital
Tainan, 704
National Taiwan University Hospital
Taipei, 100
About this study
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)
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.
- Conditions
- Magnetic Resonance Imaging
- Being tested
- IOP Injection (MPB-1523)
- Keywords
- Hepatocellular Carcinoma, Magnetic Resonance Imaging
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IOP Injection (MPB-1523)Drug
Also called MRI Contrast Agent
one dose, once IV injection at Day 1
| Study group | Role | What they receive |
|---|---|---|
| single arm: IOP injection (MPB-1523) | Experimental | single group treatment Receives: Drug: IOP Injection (MPB-1523) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: After IOP injection administration within 60 mins
Secondary outcomes (3)
Optimal time to perform a MRI scan after injection of IOP
Optimal time of IOP Injection
Measured: After IOP injection administration within 60 mins
The Number of lesions detected in liver
The sensitivity of IOP Injection
Measured: After IOP injection administration within 60 mins
The size of lesions detected in liver
The sensitivity of IOP Injection
Measured: After IOP injection administration within 60 mins
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2018
- Study start22 Nov 2018
- Primary completion30 Aug 2020
- Study completion30 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Magnetic Resonance ImagingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- MegaPro Biomedical Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Chien-Hung Chen, MD, Principal investigator, National Taiwan University HospitalDavid Wang, MD, Study director, MegaPro Biomedical Co. Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03407495
- Sponsor's protocol ID
- IOP-CT-003
- Status last verified
- Oct 2021
- First submitted
- 15 Jan 2018
- Last updated
- 22 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT03407495
- Acronym / sponsor ID
- IOP-CT-003
- Conditions
- Magnetic Resonance Imaging
- Keywords
- Hepatocellular Carcinoma, Magnetic Resonance Imaging
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- MegaPro Biomedical Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 22 Nov 2018 (actual)
- Primary completion
- 30 Aug 2020 (actual)
- Study completion
- 30 Oct 2020 (actual)
- First posted
- 23 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| single arm: IOP injection (MPB-1523) | Experimental | Drug: IOP Injection (MPB-1523)single group treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (10 listed)
- 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].
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IOP Injection (MPB-1523)Also: MRI Contrast Agentone dose, once IV injection at Day 1 | Drug | single arm: IOP injection (MPB-1523) |
Primary outcome
The Sensitivity and specificity of IOP-enhanced MRI
Time frame: After IOP injection administration within 60 mins
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.
3 secondary outcomes
Optimal time to perform a MRI scan after injection of IOP
Time frame: After IOP injection administration within 60 mins
The Number of lesions detected in liver
Time frame: After IOP injection administration within 60 mins
The size of lesions detected in liver
Time frame: After IOP injection administration within 60 mins
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chien-Hung Chen, MD principal investigator
National Taiwan University Hospital
David Wang, MD study director
MegaPro Biomedical Co. Ltd.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing IOP Injection (MPB-1523) in people with Magnetic Resonance Imaging, run by MegaPro Biomedical Co. Ltd. at 5 sites in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Sensitivity and specificity of IOP-enhanced MRI (time frame: After IOP injection administration within 60 mins). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2021.