Ferumoxytol-enhanced Magnetic Resonance Venography in Patients With Venous Diseases

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

The purpose of this single-center, prospective, evaluator-blinded study is to establish and optimize the imaging protocol for ferumoxytol-enhanced magnetic resonance venography (Fe-MRV) in patients with venous system diseases.

Current gadolinium-based contrast agents used in MRI have limitations, including short circulation half-lives and potential risks for patients with renal impairment. Ferumoxytol, a superparamagnetic iron oxide nanoparticle, offers a longer imaging window and no renal toxicity, making it a promising alternative for vascular imaging.

This study will enroll 50 adult patients with suspected or confirmed venous structural abnormalities or circulation disorders. To determine the minimum effective diagnostic dose, each participant will receive a total dose of 3.0 mg/kg, administered as four equal intravenous aliquots, with MRI performed after each aliquot (cumulative doses: 0.75, 1.50, 2.25, and 3.0 mg/kg). Independent, blinded radiologists will evaluate the image quality at each cumulative dose level to determine the lowest possible dose required to achieve successful clinical diagnosis.

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.