Assessment of Renal Vasculature and Function with Ferumoxytol-enhanced Magnetic Resonance Imaging

NCT ID: NCT05045872

Last Updated: 2024-09-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-17
• Study Completion Date: 2024-09-03

Brief Summary

Conventional contrast-enhanced magnetic resonance imaging is typically performed with extracellular gadolinium chelates, which is often limited in patients with CKD owing to the risk of nephrogenic systemic fibrosis. Ferumoxytol, a novel contrast medium, can be used as an "off-label" contrast agent for magnetic resonance imaging. During the last decade, ferumoxytol has gained appeal as an MRI contrast agent in patients with estimated glomerular filtration rates <30mL/min and there are reports in the literature for its safe use and utility in both adult and pediatric patients with CKD. The study is designed to evaluate the diagnostic performance of ferumoxytol-enhanced magnetic resonance imaging in patients suspected of renal artery stenosis, investigate the correlation between renal cortical T2*(T2*=1/R2*) and renal function, and develop an automatic algorithms for renal vessel segmentation.

Detailed Description

This study is a single-center, prospective, controlled and diagnostic clinical trial to evaluate renal vasculature and renal function with ferumoxytol-enhanced magnetic resonance imaging using domestic polysaccharide superparamagnetic iron oxide injection as the contrast agent. This study will enroll 40 patients with or without renal impairment that are expected to undergo renal artery angiography in China. The investigators will record the baseline data of patients after admission. Patients will receive enhanced renal magnetic resonance imaging with polysaccharide superparamagnetic iron oxide nanoparticle to assess renal vasculature and renal function. The related laboratory indices will be reviewed at 24-72 h after magnetic resonance imaging, and then patients will receive renal angiography. The indices will be reexamined at 1 month and 3 months after magnetic resonance imaging. In order to evaluate the safety of polysaccharide superparamagnetic iron oxide nanoparticle, patients will detect iron levels in peripheral and tissue before and after the examination. The results of MR imaging including image quality, degree of vascular stenosis, and quantitative T2* values of the renal cortex will be evaluated independently by two experienced radiologists. The degree of stenosis of the same vessels assessed by Quantitative Coronary Analysis (QCA) will be used for comparison with MR results. All clinical adverse events will be recorded by investigators.

Conditions

Chronic Kidney Diseases

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

ferumoxytol-enhanced renal magnetic resonance imaging

Patients will receive ferumoxytol-enhanced renal magnetic resonance imaging before renal angiography. Ferumoxytol (510 mg/17mL; Chia Tai Tianqing Pharmaceutical Group Co Ltd, Nanjing, China) will be diluted at 1:4 (v/v) and intravenously infused into the antecubital vein at a dose of 3 mg/kg with an infusion speed of 0.07 mL/s.

Group Type: EXPERIMENTAL

domestic polysaccharide superparamagnetic iron oxide nanoparticle

Intervention Type: DRUG

Patients will receive contrast-enhanced renal magnetic resonance imaging with polysaccharide superparamagnetic iron oxide nanoparticle before renal angiography. Patients received intravenous polysaccharide superparamagnetic iron oxide nanoparticle before magnetic resonance imaging.

Interventions

domestic polysaccharide superparamagnetic iron oxide nanoparticle

Patients will receive contrast-enhanced renal magnetic resonance imaging with polysaccharide superparamagnetic iron oxide nanoparticle before renal angiography. Patients received intravenous polysaccharide superparamagnetic iron oxide nanoparticle before magnetic resonance imaging.

Intervention Type: DRUG

Other Intervention Names

ferumoxytol

Eligibility Criteria

Inclusion Criteria

• Age ≧ 18 years, < 75 years;
• Patients who planned renal angiography (hypertension 、renal failure、atherosclerosis）;
• Patients with normal renal function or CKD stage 1-5(Patients diagnosed with CKD as defined in the KDIGO Clinical Practice Guidelines for the Evaluation and Management of Chronic Kidney Disease 2012 Edition);
• Patients themselves or authorized families to sign informed consent voluntarily.

Exclusion Criteria

• Patients who were allergic to iodine contrast agent or had allergic history or allergic constitution to iron and dextran;
• Patients who can't accept magnetic resonance examination because of psychological ( such as Claustrophobia ) or physical reasons ( such as metal retention in the body );
• Malignancies or other comorbid conditions with life expectancy less than 1 year;
• Pregnant or lactating women;
• Hearing impaired persons;
• Cardiac function grade III-IV;
• Patients who were taking other iron agents orally or intravenously;
• Patients with hemosiderin deposition or hemochromatosis;
• Patients with acute coronary syndromes;
• Any other patients that researcher deems it's unsuitable to be admitted.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

INDUSTRY

Sponsor Role: collaborator

The First Affiliated Hospital with Nanjing Medical University

OTHER

Sponsor Role: lead

Responsible Party

Chunjian Li

Dr., MD, Ph.D, Director of CCU Ward

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Chunjian Li, Dr,PhD

Role: PRINCIPAL_INVESTIGATOR

Study Principal Investigator

Locations

First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

Countries

China

Other Identifiers

013

Identifier Type: -

Identifier Source: org_study_id