Ferumoxytol-enhanced Magnetic Resonance Venography in Patients With Venous Diseases

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.

Timeline

Start

2026-03-08

Primary completion

2026-08

Completion

2026-08

Publications

• Background 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.
• 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.
• 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.
• 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.
• 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.

Drugs

Indications