Assessment of Renal Vasculature and Function with Ferumoxytol-enhanced Magnetic Resonance Imaging (NCT05045872) | Clinical Trial Compass
CompletedPhase 1
Assessment of Renal Vasculature and Function with Ferumoxytol-enhanced Magnetic Resonance Imaging
China44 participantsStarted 2021-09-17
Plain-language 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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
the degree of renal artery stenosis
Timeframe: baseline and after intervention
2
quantitative cortical T2* value
Timeframe: baseline and after intervention
3
change of hemoglobin level
Timeframe: baseline,72 hours,30 days,3 months
4
serum creatinine
Timeframe: baseline,72 hours,30 days,3 months
5
Urine routine
Timeframe: baseline,72 hours,30 days,3 months
6
24-hour urine biochemistry
Timeframe: baseline,72 hours,30 days,3 months
7
Retinol binding protein
Timeframe: baseline,72 hours,30 days,3 months
8
Neutrophil gelatinase-associated lipocalin
Trial details
NCT IDNCT05045872
SponsorThe First Affiliated Hospital with Nanjing Medical University