Clinical trial NCT03407495: The Clinical Validity and Safety of IOP Injection MRI Contrast Agent in Hepatocellular Carcinoma
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Magnetic Resonance Imaging
Keywords: Hepatocellular Carcinoma
Magnetic Resonance Imaging
Lead sponsor: MegaPro Biomedical Co. Ltd.
Sponsor class: INDUSTRY
First posted: 2018-01-23
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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

Eligibility criteria: 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:

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.

Primary outcomes:
measure: The Sensitivity and specificity of IOP-enhanced MRI
timeFrame: After IOP injection administration within 60 mins
Secondary outcomes:
measure: Optimal time to perform a MRI scan after injection of IOP
timeFrame: After IOP injection administration within 60 mins
measure: The Number of lesions detected in liver
timeFrame: After IOP injection administration within 60 mins
measure: The size of lesions detected in liver
timeFrame: After IOP injection administration within 60 mins
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Chang Gung Medical Foundation
city: Taichung
country: Taiwan
facility: China Medical University Hospital
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Chien-Hung Chen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: MegaPro Biomedical Co. Ltd.
name: David Wang, MD
role: STUDY_DIRECTOR
References: