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

November 1, 2023 updated by: Chunjian Li, The First Affiliated Hospital with Nanjing Medical University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210029
        • Recruiting
        • First Affiliated Hospital of Nanjing Medical University
        • Contact:
        • Contact:
          • Fuming Zhang, M.D.
          • Phone Number: 6360 +86-25-83718836
          • Email: jsphkj@163.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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.
Other Names:
  • ferumoxytol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change of hemoglobin level
Time Frame: baseline,72 hours,30 days,3 months
hemoglobin examination of patients before and after examination to evaluate anemia.
baseline,72 hours,30 days,3 months
serum creatinine
Time Frame: baseline,72 hours,30 days,3 months
serum creatinine examination of patients before and after examination to evaluate kidney function.
baseline,72 hours,30 days,3 months
Urine routine
Time Frame: baseline,72 hours,30 days,3 months
Urine routine examination of patients before and after examination to evaluate kidney function.
baseline,72 hours,30 days,3 months
24-hour urine biochemistry
Time Frame: baseline,72 hours,30 days,3 months
24-hour urine biochemistry examination of patients before and after examination to evaluate kidney function.
baseline,72 hours,30 days,3 months
Retinol binding protein
Time Frame: baseline,72 hours,30 days,3 months
Retinol binding protein examination of patients before and after examination to evaluate kidney function.
baseline,72 hours,30 days,3 months
Neutrophil gelatinase-associated lipocalin
Time Frame: baseline,72 hours,30 days,3 months
Neutrophil gelatinase-associated lipocalin examination of patients before and after examination to evaluate kidney function.
baseline,72 hours,30 days,3 months
Serum iron
Time Frame: baseline,72 hours,30 days,3 months
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
Ferritin
Time Frame: baseline,72 hours,30 days,3 months
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
Transferrin
Time Frame: baseline,72 hours,30 days,3 months
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
the degree of renal artery stenosis
Time Frame: baseline and after intervention
Degree of renal artery stenosis assessed by Magnetic Resonance Imaging and renal angiography
baseline and after intervention
quantitative cortical T2* value
Time Frame: baseline and after intervention
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
serum cystatin C
Time Frame: baseline,72 hours,30 days,3 months
Determination of serum cystatin C before and after examination to evaluate the changes of renal function.
baseline,72 hours,30 days,3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The First Affiliated Hospital with Nanjing Medical University

Collaborators

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Investigators

  • Principal Investigator: Chunjian Li, Dr,PhD, Study Principal Investigator

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 17, 2021

Primary Completion (Estimated)

May 30, 2024

Study Completion (Estimated)

June 30, 2024

Study Registration Dates

First Submitted

August 21, 2021

First Submitted That Met QC Criteria

September 14, 2021

First Posted (Actual)

September 16, 2021

Study Record Updates

Last Update Posted (Actual)

November 2, 2023

Last Update Submitted That Met QC Criteria

November 1, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 013

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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