Clinical Study of Domestic Polysaccharide Superparamagnetic Iron Oxide Nanoparticle Injection for Renal Contrast-enhanced Magnetic Resonance Imaging
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Ferritin
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: domestic polysaccharide superparamagnetic iron oxide nanoparticle (Drug)
结局指标
主要结局
Ferritin
时间窗: 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.
the degree of renal artery stenosis
时间窗: baseline and after intervention
Degree of renal artery stenosis assessed by Magnetic Resonance Imaging and renal angiography
change of hemoglobin level
时间窗: baseline,72 hours,30 days,3 months
hemoglobin examination of patients before and after examination to evaluate anemia.
Urine routine
时间窗: baseline,72 hours,30 days,3 months
Urine routine examination of patients before and after examination to evaluate kidney function.
24-hour urine biochemistry
时间窗: baseline,72 hours,30 days,3 months
24-hour urine biochemistry examination of patients before and after examination to evaluate kidney function.
Serum iron
时间窗: 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.
Retinol binding protein
时间窗: baseline,72 hours,30 days,3 months
Retinol binding protein examination of patients before and after examination to evaluate kidney function.
quantitative cortical T2* value
时间窗: 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.
serum creatinine
时间窗: baseline,72 hours,30 days,3 months
serum creatinine examination of patients before and after examination to evaluate kidney function.
Neutrophil gelatinase-associated lipocalin
时间窗: baseline,72 hours,30 days,3 months
Neutrophil gelatinase-associated lipocalin examination of patients before and after examination to evaluate kidney function.
Transferrin
时间窗: 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.
serum cystatin C
时间窗: baseline,72 hours,30 days,3 months
Determination of serum cystatin C before and after examination to evaluate the changes of renal function.
次要结局
未报告次要终点
研究者
Chunjian Li
Dr., MD, Ph.D, Director of CCU Ward
The First Affiliated Hospital with Nanjing Medical University