Clinical Trials Logo
  1. Home
  2. Magnetic Resonance Imaging
  3. NCT02744248

Phase I , MTD, Pharmacokinetic, Safety/Tolerability, Efficacy of IOP Injection for MRI in Healthy Subjects

Magnetic Resonance Imaging Clinical Trial

Official title:
A Phase I Study to Determine the MTD and to Evaluate Pharmacokinetic, Safety/Tolerability, and Efficacy Profiles of IOP Injection for MRI Contrast Agent in Healthy Subjects

Clinical Trial Summary

Study Objectives Primary: To determine MTD and dose limiting toxicities (DLTs) of IOP magnetic resonance imaging (MRI) contrast agent in healthy subjects.

Secondary:

1. To characterize the pharmacokinetic profiles of IOP MRI contrast agent in healthy subjects.

2. To evaluate safety/tolerability profiles of IOP MRI contrast agent in healthy subjects.

3. To explore efficacy profiles of IOP MRI contrast agent for liver organ in healthy subjects.

Clinical Trial Description

Iron Oxide Nano Particle m-PEG-silane (IOP) Injection belongs to Superparamagnetic iron oxide (SPIO) can shorten the T2 relaxation time very effectively and reduces signal intensity in normal tissues. The mechanism of action increases after the particles have been phagocytosed by cells of the RES. Tissues with decreased RES function (e.g., metastases, primary liver cancer, cysts and various benign tumors, adenomas, and hyperplasia) retain their native signal intensity. In this study, investigators will characterize the PK profile, iron metabolism and preliminary efficacy of IOP Injection. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02744248
Study type Interventional
Source MegaPro Biomedical Co. Ltd.
Contact
Status Completed
Phase Phase 1
Start date February 2016
Completion date December 2017
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT03785171 - Predicative Value of Multimodal MRI in Moyamoya Disease
Not yet recruiting NCT03726788 - Intra Articular Injection of Botulinum Toxin Versus Corticoids in Gonarthrosis Phase 2
Active, not recruiting NCT01956409 - Proton MR Spectroscopy and 18F-Fluorocholine PET for Breast Cancer Diagnosis Phase 4
Completed NCT01660841 - Safety and Efficacy of Gadobutrol 1.0 Molar in Japanese Subjects for CNS Imaging Phase 3
Recruiting NCT03635619 - The Application of 3T MRI in Esophageal Cancer
Recruiting NCT03658343 - T2* MRI Analysis for Sarcoma N/A
Recruiting NCT04555642 - Early Diagnosis of Therapy-associated Cardiotoxicity Basing on Multi-tracer Multimodality PET/MRI
Active, not recruiting NCT03441867 - Neuroimaging Biomarker for Seizures N/A
Recruiting NCT04850001 - Cognitive Decline in Asymptomatic Intracranial Stenosis Patients: A 1-Year Follow-Up Study
Not yet recruiting NCT05816213 - Point-of-care Low-field MRI in Acute Stroke
Active, not recruiting NCT05498623 - MR Fingerprinting for Diagnostic of Prostate Cancer
Recruiting NCT04996615 - Artificial Intelligence Analysis for Magnetic Resonance Imaging in Screening Breast Cancer in High-risk Women
Recruiting NCT04257747 - Qualitative and Quantitative Evaluation of Vascular Flows of Radial, Ulnar and Interdigital Arterial Trees Under Normal and Pathological Conditions by 3 Tesla MRI N/A
Recruiting NCT05889117 - Brain Stimulation for Concussion N/A
Completed NCT02540967 - Drug Use Investigation of Gadovist.
Completed NCT05103189 - 4D-flow Cardiac MRI to Assess Pulmonary Arterial Pressure in Pulmonary Hypertension N/A
Completed NCT02567318 - Is the Volume of the Caudate Nuclei Associated With Area of Secondary Hyperalgesia? N/A
Recruiting NCT02834585 - Magnetic Resonance Imaging or Ultrasound in Soft Tissue Tumors (MUSTT) N/A
Active, not recruiting NCT02446665 - Disease Status in Primary Sclerosing Cholangitis by Elastography N/A
Completed NCT01721785 - Diagnostic Value of Novel MR Imaging Techniques for the Primary Staging and Restaging of Rectal Cancer N/A