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NCT Number: NCT05045872

Assessment of Renal Vasculature and Function with Ferumoxytol-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.

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Key information

Conditions

Chronic Kidney Diseases Arterial Occlusive Diseases Cardiovascular Diseases Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Artery Obstruction Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases Vascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210029, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

domestic polysaccharide superparamagnetic iron oxide nanoparticle

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.

Other names: ferumoxytol

Primary outcomes

  1. 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

  2. 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.

  3. change of hemoglobin level

    Time frame: baseline,72 hours,30 days,3 months

    hemoglobin examination of patients before and after examination to evaluate anemia.

  4. serum creatinine

    Time frame: baseline,72 hours,30 days,3 months

    serum creatinine examination of patients before and after examination to evaluate kidney function.

  5. Urine routine

    Time frame: baseline,72 hours,30 days,3 months

    Urine routine examination of patients before and after examination to evaluate kidney function.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital with Nanjing Medical University

Other

Collaborators

  • Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Sep 16, 2021
Registry last updated
Sep 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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