Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT07452250

Ferumoxytol-enhanced Magnetic Resonance Venography in Patients With Venous Diseases

Led by Min Zhou · Updated on 2026-03-11

50

Participants Needed

1

Research Sites

20 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Ferumoxytol-enhanced Magnetic Resonance Venography in Patients With Venous Diseases

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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.
Not Eligible

You will not qualify if you...

  • 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.

AI-Screening

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Trial Site Locations

Total: 1 location

1

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Nanjing, Jiangsu, China, 210008

Actively Recruiting

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Research Team

G

Guangxiang Si

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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