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

NCT03407495 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2021-10-22

No results posted yet for this 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.

Conditions

  • Magnetic Resonance Imaging

Interventions

DRUG

IOP Injection (MPB-1523)

one dose, once IV injection at Day 1

Sponsors & Collaborators

  • MegaPro Biomedical Co. Ltd.

    lead INDUSTRY

Principal Investigators

  • Chien-Hung Chen, MD · National Taiwan University Hospital

  • David Wang, MD · MegaPro Biomedical Co. Ltd.

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-22
Primary Completion
2020-08-30
Completion
2020-10-30
FDA Drug
Yes

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03407495 on ClinicalTrials.gov