Using Ferumoxytol for MRI in Atherosclerosis Patients
Clinical Research Protocol of Ferumoxytol for Magnetic Resonance Enhancement Imaging in Patients With Atherosclerosis.
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School · NCT06551805
This study is testing if Ferumoxytol can be safely used as a contrast agent during MRI scans to help people with atherosclerosis get better images of their blood vessels.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School (other) |
| Locations | 1 site (Nanjing, Jiangsu) |
| Trial ID | NCT06551805 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the safety and effectiveness of Ferumoxytol as a contrast agent for magnetic resonance angiography (MRA) in patients with atherosclerosis. Participants will undergo safety assessments through vital signs and laboratory tests before and after Ferumoxytol administration. Following the injection, patients will have two MRI scans at specified intervals to assess the diagnostic utility of Ferumoxytol. The study will prospectively enroll eligible patients and document their pre-administration lab results as part of routine clinical assessments.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 years and older diagnosed with atherosclerosis.
Not a fit: Patients with a history of allergic reactions to iron products or those unable to undergo MRI will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the diagnostic capabilities for patients with atherosclerosis, leading to better management of their condition.
How similar studies have performed: While the use of Ferumoxytol in imaging is being explored, this specific application for atherosclerosis is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria: Patients aged 18 years and older with atherosclerosis. Exclusion criteria: Individuals with a history of allergy or hypersensitivity to iron or dextran. Patients currently receiving oral or intravenous iron therapy. Patients with hemosiderosis or hemochromatosis. Patients with a history of allergic reactions to intravenous iron products or any iron overload-related conditions. Individuals who are unable to undergo magnetic resonance imaging (MRI) due to psychological reasons (such as claustrophobia) or physical reasons (such as the presence of non-compatible metallic objects in the body). Patients with end-stage diseases or life expectancy less than 1 year. Pregnant women. Any other individuals deemed unsuitable for inclusion by the investigator.
Where this trial is running
Nanjing, Jiangsu
- Department of Radiology, the Affiliated Drum Tower Hospital of Nanjing University — Nanjing, Jiangsu, China (RECRUITING)
Study contacts
- Study coordinator: Jing Liang
- Email: liangjingxyz@163.com
- Phone: 18262638917
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Atherosclerosis