Ferumoxytol-enhanced MR venography for people with venous disease
Official title: A Single-center, Evaluator-blinded Clinical Study of Polysaccharide Superparamagnetic Iron Oxide Injection for Magnetic Resonance Venography in Patients With Venous System Diseases
Run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School · NCT07452250 · Data updated 2026-11-12
This trial will test whether ferumoxytol, an iron-based MRI contrast agent, produces clear venous images in adults with suspected or confirmed venous disease.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 50 (estimated) |
| Sponsor | The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School Academic / other |
| Locations | 1 site (Nanjing, Jiangsu) |
| Status | Recruiting |
| Started | March 8, 2026 |
| Main results expected | August 2026 |
| Study ends | August 2026 |
| Registry record updated | March 11, 2026 |
| Trial ID | NCT07452250 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18 or older with suspected or preliminarily diagnosed venous structural abnormalities or circulation disorders who can give written informed consent are the intended participants.
✕Probably not a fit
People who are pregnant, have iron overload conditions, prior hypersensitivity to intravenous iron, are currently receiving other iron products, or cannot undergo MRI (for example due to incompatible implants or severe claustrophobia) are unlikely to benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This single-center, prospective, evaluator-blinded Phase 2 trial will enroll 50 adults with suspected or confirmed venous structural abnormalities or circulation disorders. Each participant will receive a total ferumoxytol dose of 3.0 mg/kg given as four equal intravenous aliquots, with MR venography performed after each aliquot to identify the minimum effective diagnostic dose (0.75, 1.50, 2.25, and 3.0 mg/kg cumulative). Independent, blinded radiologists will rate image quality at each dose level to optimize the imaging protocol. The protocol is intended to leverage ferumoxytol's longer blood-pool residence and lack of renal toxicity compared with gadolinium-based agents.
Why it matters
Potential benefit: If successful, this approach could provide clearer venous MR images and offer a safer contrast option for patients with impaired kidney function.
How similar studies have gone: Previous clinical work has shown ferumoxytol can be useful as an alternative vascular MRI contrast, particularly in patients with renal impairment, though optimal dosing for venography remains under study.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age \>= 18 years. * Suspected or preliminarily diagnosed venous structural abnormalities (e.g., lower-extremity veins, central veins) or venous circulation disorders requiring Fe-MRV evaluation. * Able and willing to provide written informed consent. Exclusion Criteria: * History of allergy/hypersensitivity to iron or dextran, or known allergy-prone constitution. * Currently receiving other oral or intravenous iron products. * Hemosiderosis or hemochromatosis. * Prior hypersensitivity reaction to intravenous iron products, or any condition associated with iron overload. * Unable to undergo MRI for psychological reasons (e.g., claustrophobia) or physical reasons (e.g., non-MRI-compatible metallic implants/foreign bodies). * End-stage disease or life expectancy \< 1 year. * Pregnant women. * Any other condition judged by the investigator to make the participant unsuitable for the study.
Where it's running
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The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Nanjing, Jiangsu, China Recruiting
Study contacts
- Study coordinator: Guangxiang Si
- Email: guangxiang_si@163.com
- Phone: +86-17320005863
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.