Ferumoxytol-enhanced Magnetic Resonance Venography in Patients With Venous Diseases

NCT07452250 | Recruiting Phase 2

• 1 other identifier: 2025-0616-02
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Venous Diseases

Outcome Measures

Primary Outcomes (1)

• Overall Diagnostic Success Rate

  The overall diagnostic success rate is defined as the proportion of vascular segments with an average image quality score of ≥ 3 (evaluated on a 5-point Likert scale, where 1 = non-diagnostic/unusable and 5 = excellent). A segment is considered successfully diagnosed only if two independent, blinded radiologists reach a consensus that it is "diagnosable".

  Up to 2 days post-intervention

Secondary Outcomes (2)

• Signal-to-Noise Ratio (SNR) Assessed by Ferumoxytol-enhanced Magnetic Resonance Venography

  Up to 2 days post-intervention

• Contrast-to-Noise Ratio (CNR) Assessed by Ferumoxytol-enhanced Magnetic Resonance Venography

  Up to 2 days post-intervention

Study Arms (1)

Fe-MRV Dose Optimization Group

EXPERIMENTAL

All enrolled participants will receive a total dose of 3.0 mg/kg of ferumoxytol injection. The contrast agent is administered intravenously in four equal consecutive aliquots. An MRI scan is performed after each aliquot to evaluate image quality at cumulative doses of 0.75, 1.50, 2.25, and 3.0 mg/kg.

Drug: Ferumoxytol injection

Interventions

Ferumoxytol injection DRUG

Ferumoxytol is a superparamagnetic iron oxide nanoparticle contrast agent. It is administered intravenously at a total dose of 3.0 mg/kg, divided into four equal consecutive aliquots (0.75 mg/kg each).

Fe-MRV Dose Optimization Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Min Zhou: lead

Study Sites (1)

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Nanjing, Jiangsu, 210008, China

RECRUITING

Related Publications (5)

• Stoumpos S, Hennessy M, Vesey AT, Radjenovic A, Kasthuri R, Kingsmore DB, Mark PB, Roditi G. Ferumoxytol magnetic resonance angiography: a dose-finding study in patients with chronic kidney disease. Eur Radiol. 2019 Jul;29(7):3543-3552. doi: 10.1007/s00330-019-06137-4. Epub 2019 Mar 27.

  PMID: 30919067 BACKGROUND

• Liu Y, Cao B, Wang X, Zhong J, Li Z, Peng R, Zhao D, Gu N, Yang Q. Ferumoxytol-enhanced MR venography for mapping lower-extremity venous networks and evaluating varicose veins in patients with diabetes. Eur Radiol. 2024 Nov;34(11):7197-7207. doi: 10.1007/s00330-024-10772-x. Epub 2024 May 7.

  PMID: 38713277 BACKGROUND

• Shahrouki P, Khan SN, Yoshida T, Iskander PJ, Ghahremani S, Finn JP. High-resolution three-dimensional contrast-enhanced magnetic resonance venography in children: comparison of gadofosveset trisodium with ferumoxytol. Pediatr Radiol. 2022 Mar;52(3):501-512. doi: 10.1007/s00247-021-05225-2. Epub 2021 Dec 22.

  PMID: 34936018 BACKGROUND

• Gallo CJR, Mammarappallil JG, Johnson DY, Chalian H, Ronald J, Bashir MR, Kim CY. Ferumoxytol-enhanced MR Venography of the Central Veins of the Thorax for the Evaluation of Stenosis and Occlusion in Patients with Renal Impairment. Radiol Cardiothorac Imaging. 2020 Nov 19;2(6):e200339. doi: 10.1148/ryct.2020200339. eCollection 2020 Dec.

  PMID: 33778639 BACKGROUND

• Bashir MR, Mody R, Neville A, Javan R, Seaman D, Kim CY, Gupta RT, Jaffe TA. Retrospective assessment of the utility of an iron-based agent for contrast-enhanced magnetic resonance venography in patients with endstage renal diseases. J Magn Reson Imaging. 2014 Jul;40(1):113-8. doi: 10.1002/jmri.24330. Epub 2013 Oct 15.

  PMID: 24130008 BACKGROUND

MeSH Terms

Interventions

Ferrosoferric Oxide

Intervention Hierarchy (Ancestors)

Ferric Compounds; Iron Compounds; Inorganic Chemicals; Ferrous Compounds; Minerals

Central Study Contacts

Guangxiang Si

CONTACT

+86-17320005863; guangxiang_si@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief Physician (Vascular Surgery)

Study Record Dates

• First Submitted: February 28, 2026
• First Posted: March 5, 2026
• Study Start: March 8, 2026
• Primary Completion: August 1, 2026
• Study Completion: August 1, 2026
• Last Updated: March 11, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)