Ferumoxytol-enhanced MR venography for people with venous disease

A Single-center, Evaluator-blinded Clinical Study of Polysaccharide Superparamagnetic Iron Oxide Injection for Magnetic Resonance Venography in Patients With Venous System Diseases

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: PHASE2
• Study type: Interventional
• Enrollment: 50 (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: NCT07452250 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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.

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 performed: 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.

Eligibility 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 this trial is running

Nanjing, Jiangsu

• The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School — Nanjing, Jiangsu, China (RECRUITING)

Study contacts

• Study coordinator: Guangxiang Si

Conditions: Venous Diseases