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

Chronic Kidney Diseases Clinical Trial

Official title:

Clinical Study of Domestic Polysaccharide Superparamagnetic Iron Oxide Nanoparticle Injection for Renal Contrast-enhanced Magnetic Resonance Imaging

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05045872
• Other study ID #: 013
• Status: Recruiting
• Phase: Phase 1
• Start date: September 17, 2021
• Est. completion date: June 30, 2024

Study information

• Verified date: November 2023
• Source: The First Affiliated Hospital with Nanjing Medical University
• Contact: Chunjian Li, Dr,PhD
• Phone: +86-13701465229
• Email: drcjli[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: June 30, 2024
• Est. primary completion date: May 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Kidney Diseases
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
China	First Affiliated Hospital of Nanjing Medical University	Nanjing	Jiangsu

Sponsors (2)

Lead Sponsor	Collaborator
The First Affiliated Hospital with Nanjing Medical University	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the degree of renal artery stenosis	Degree of renal artery stenosis assessed by Magnetic Resonance Imaging and renal angiography	baseline and after intervention
Primary	quantitative cortical T2* value	the quantitative T2* value of the renal cortex will be measured bilaterally at the upper and lower poles by drawing six equal-sized, non-overlapping operator-dependent regions of interest (ROI) to calculate average quantitative T2* values.	baseline and after intervention
Primary	change of hemoglobin level	hemoglobin examination of patients before and after examination to evaluate anemia.	baseline,72 hours,30 days,3 months
Primary	serum creatinine	serum creatinine examination of patients before and after examination to evaluate kidney function.	baseline,72 hours,30 days,3 months
Primary	Urine routine	Urine routine examination of patients before and after examination to evaluate kidney function.	baseline,72 hours,30 days,3 months
Primary	24-hour urine biochemistry	24-hour urine biochemistry examination of patients before and after examination to evaluate kidney function.	baseline,72 hours,30 days,3 months
Primary	Retinol binding protein	Retinol binding protein examination of patients before and after examination to evaluate kidney function.	baseline,72 hours,30 days,3 months
Primary	Neutrophil gelatinase-associated lipocalin	Neutrophil gelatinase-associated lipocalin examination of patients before and after examination to evaluate kidney function.	baseline,72 hours,30 days,3 months
Primary	Serum iron	Determination of serum iron before and after MRA to evaluate the changes of iron content in peripheral blood.	baseline,72 hours,30 days,3 months
Primary	Ferritin	Determination of serum ferritin before and after MRA to evaluate the changes of iron content in peripheral blood.	baseline,72 hours,30 days,3 months
Primary	Transferrin	Determination of serum transferrin before and after MRA to evaluate the changes of iron content in peripheral blood.	baseline,72 hours,30 days,3 months
Primary	serum cystatin C	Determination of serum cystatin C before and after examination to evaluate the changes of renal function.	baseline,72 hours,30 days,3 months