NCT05045872CompletedPhase 1
Assessment of Renal Vasculature and Function with Ferumoxytol-enhanced Magnetic Resonance Imaging
Clinical Study of Domestic Polysaccharide Superparamagnetic Iron Oxide Nanoparticle Injection for Renal Contrast-enhanced Magnetic Resonance Imaging
Source: ClinicalTrials.gov · Last updated 25 Sept 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 44 (actual)
- First submitted
- 21 Aug 2021
- Start date
- 17 Sept 2021
- Primary completion date
- 25 May 2024
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical University
- Diseases
- Chronic kidney disease
- NCT number
- NCT05045872
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 44
- From 17 Sept 2021 to the primary completion date, 25 May 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Patients who were allergic to iodine contrast agent or had allergic history or allergic constitution to iron and dextran;
- Malignancies or other comorbid conditions with life expectancy less than 1 year;
- Cardiac function grade III-IV;
- Patients with acute coronary syndromes;
Other
- Patients who can't accept magnetic resonance examination because of psychological ( such as Claustrophobia ) or physical reasons ( such as metal retention in the body );
- Pregnant or lactating women;
- Hearing impaired persons;
- Patients who were taking other iron agents orally or intravenously;
- Patients with hemosiderin deposition or hemochromatosis;
- Any other patients that researcher deems it's unsuitable to be admitted.
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| First Affiliated Hospital of Nanjing Medical University Coordinator of this site? Confirm its status | Nanjing | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.