NCT03407495

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Nov 2018

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 15, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 23, 2018

Completed
10 months until next milestone

Study Start

First participant enrolled

November 22, 2018

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2020

Completed
Last Updated

October 22, 2021

Status Verified

October 1, 2021

Enrollment Period

1.8 years

First QC Date

January 15, 2018

Last Update Submit

October 21, 2021

Conditions

Magnetic Resonance Imaging

Keywords

Hepatocellular CarcinomaMagnetic Resonance Imaging

Outcome Measures

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.

    After IOP injection administration within 60 mins

Secondary Outcomes (3)

  • Optimal time to perform a MRI scan after injection of IOP

    After IOP injection administration within 60 mins

  • The Number of lesions detected in liver

    After IOP injection administration within 60 mins

  • The size of lesions detected in liver

    After IOP injection administration within 60 mins

Study Arms (1)

single arm: IOP injection (MPB-1523)

EXPERIMENTAL

single group treatment

Drug: IOP Injection (MPB-1523)

Interventions

IOP Injection (MPB-1523)DRUG

one dose, once IV injection at Day 1

Also known as: MRI Contrast Agent
single arm: IOP injection (MPB-1523)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Chang Gung Medical Foundation

Kaohsiung City, 833, Taiwan

Location

China Medical University Hospital

Taichung, 404, Taiwan

Location

Taichung Veterans General Hospital

Taichung, 407, Taiwan

Location

National Cheng Kung University Hospital

Tainan, 704, Taiwan

Location

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Study Officials

  • Chien-Hung Chen, MD

    National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

  • David Wang, MD

    MegaPro Biomedical Co. Ltd.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 15, 2018

First Posted

January 23, 2018

Study Start

November 22, 2018

Primary Completion

August 30, 2020

Study Completion

October 30, 2020

Last Updated

October 22, 2021

Record last verified: 2021-10

Locations

TW(5)