NCT07452250 Ferumoxytol-enhanced Magnetic Resonance Venography in Patients With Venous Diseases
| NCT ID | NCT07452250 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Min Zhou |
| Condition | Venous Diseases |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2026-03-08 |
| Primary Completion | 2026-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 50 participants in total. It began in 2026-03-08 with a primary completion date of 2026-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07452250 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Venous Diseases. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07452250 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07452250 currently recruiting?
Yes, NCT07452250 is actively recruiting participants. Contact the research team at guangxiang_si@163.com for enrollment information.
Where is the NCT07452250 trial being conducted?
This trial is being conducted at Nanjing, China.
Who is sponsoring the NCT07452250 clinical trial?
NCT07452250 is sponsored by Min Zhou. The trial plans to enroll 50 participants.