Clinical Trials List
2018-08-23 - 2020-07-31
Phase II
Not yet recruiting6
Terminated1
ICD-10C22
Malignant neoplasm of liver and intrahepatic bile ducts
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 patients with Hepatocellular Carcinoma (HCC)
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Trial Applicant
MegaPro Biomedical Co., Ltd.
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Sponsor
MegaPro Biomedical Company Limited
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Trial scale
Multi-Regional Multi-Center
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Update
2025/08/20
Investigators and Locations
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Co-Principal Investigator
- 楊宏仁 Division of Others
- 陳永芳 Division of Others
- 陳德鴻 Division of Others
- Wei-Ching Lin Division of Others -
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Co-Principal Investigator
Audit
None
Co-Principal Investigator
- Ming-Chih Ho Division of General Surgery
- - - Division of Radiology
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Audit
None
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Co-Principal Investigator
- 吳毅晉 Division of General Internal Medicine
- Liu Yi-Sheng Division of General Internal Medicine
- 簡世杰 Division of General Internal Medicine
- Chiu Hung Chiu Division of General Internal Medicine
- Yih-Jyh Lin Division of General Internal Medicine
- 林典慶 Division of General Internal Medicine
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Audit
None
Condition/Disease
Objectives
Test Drug
Active Ingredient
Dosage Form
Dosage
Endpoints
predictive value of IOP-enhanced MRI compared to dynamic multiphase MDCT for the
detection of HCC. Up to 45 subjects with suspected HCC will be included.
Primary Clinical Validity Variable:
• Sensitivity and specificity of IOP-enhanced MRI compared to dynamic multiphase
MDCT for the detection of HCC
Inclution Criteria
1. Male and female subjects ≥18 years of age
2. Patients with suspected HCC scheduled for partial hepatic resection within 4
weeks of planned dynamic multiphase MDCT or IOP-enhanced MRI, whichever
is later.
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 within a maximum of 28 days before IOP-enhanced MRI.
4. Able to tolerate IOP-enhanced MRI and dynamic multiphase MDCT procedures.
5. Male subjects who have not undergone a successful vasectomy and who are
partners of women of child-bearing potential, must use, or their partners must use,
a highly effective method of contraception starting from at least one menstrual
cycle prior to starting study drug(s) and throughout the entire study period and for
30 days after the last dose of study drug. Female subject of child-bearing potential
must also use contraception.
6. Ability to provide written, personally signed, and dated informed consent to
participate in the study, in accordance with the International Conference on
Harmonisation Good Clinical Practice Guideline E6 and applicable regulations,
before completing any study related procedures.
Exclusion Criteria
1. Subjects who received any previous treatment for HCC.
2. Subjects with a serious allergic history or known allergy to similar ingredients of
the study contrast agent (i.e., Gd-based and SPIO particles contrast agents).
3. Subjects with a positive human immunodeficiency virus test.
4. Subjects with severe renal insufficiency as defined by an estimated glomerular
filtration rate (eGFR) ≤ 30 mL/min/1.73 m2
by Chronic Kidney Disease
Epidemiology Collaboration equation.
5. Subjects with severe liver disease as defined by Child-Pugh class C cirrhosis.
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, including but not
limited to pacemakers, neurostimulators, biostimulators, implanted insulin pumps,
aneurysm clips, bioprosthesis, artificial limb, metallic fragment or foreign body,
shunt, surgical staples (including clips or metallic sutures and/or ear implants.)
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 (e.g. due to surgery, acute myocardial
infarction).
11. In the investigator's opinion, subject suffers from any physical, psychological or
other condition(s) that might interfere with the conduct of the MRI, such as severe
claustrophobia.
12. Subject judged by the investigator or co- investigator as unsuitable for the study.
13. Subjects with known hemochromatosis.
The Estimated Number of Participants
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Taiwan
0 participants
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Global
60 participants
