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Venous DiseasesPhase 2NCT07452250

Ferumoxytol-enhanced Magnetic Resonance Venography in Patients With Venous Diseases

A Phase 2 study testing Ferumoxytol injection in people with Venous Diseases, run by Min Zhou at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Venous Diseases
What is being tested?
Ferumoxytol injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteChina
Study dates
8 Mar 2026to Aug 2026
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Guangxiang Si contact

+86-17320005863

guangxiang_si@163.com

China1 site, 1 recruiting

  • The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

    Nanjing, Jiangsu, 210008

    Guangxiang Si, +86-17320005863, guangxiang_si@163.com

    Recruiting

Other trials in China

About this study

Official title: 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.

Conditions
Venous Diseases
Being tested
Ferumoxytol injection

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ferumoxytol injectionDrug

    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).

Study groups in NCT07452250
Study groupRoleWhat they receive
Fe-MRV Dose Optimization GroupExperimentalAll 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.
Receives: Drug: Ferumoxytol injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  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".

    Measured: Up to 2 days post-intervention

Secondary outcomes (2)

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

    Signal intensity measurements will be performed using RadiAnt DICOM Viewer software. For each vascular segment, an elliptical region of interest (ROI) covering approximately two-thirds of the vascular lumen will be employed to minimize the effect of partial volume effects. SNR is calculated as the mean signal intensity of the vessel divided by the standard deviation (SD) of the vessel signal intensity. The vessel SD is used in place of background SD, as SNR calculated using background SD is inconsistent across regions of an accelerated sparse image.

    Measured: Up to 2 days post-intervention

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

    Signal intensity measurements will be performed using RadiAnt DICOM Viewer software. For each vascular segment, an elliptical ROI covering approximately two-thirds of the vascular lumen will be employed to minimize partial volume effects. The reference signal and standard deviation (SD) of the adjacent muscle will be measured on the same slice. CNR is calculated as the difference between the mean signal intensity of the vessel and that of the adjacent muscle, divided by the square root of the sum of the squared SDs of the vessel and the adjacent muscle.

    Measured: Up to 2 days post-intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Mar 2026
  2. Study start8 Mar 2026
  3. Primary completionAug 2026 (estimated)
  4. Study completionAug 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07452250
Sponsor's protocol ID
2025-0616-02
Status last verified
Mar 2026
First submitted
28 Feb 2026
Last updated
11 Mar 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data (IPD) will not be shared to protect patient privacy and comply with the hospital's data security and management policies.

Publications

  • 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.

    PubMed 30919067

  • 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.

    PubMed 38713277

  • 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.

    PubMed 34936018

  • 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.

    PubMed 33778639

  • 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.

    PubMed 24130008

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Ferumoxytol injection in people with Venous Diseases, run by Min Zhou at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 11 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Guangxiang Si (+86-17320005863, guangxiang_si@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Diagnostic Success Rate (time frame: Up to 2 days post-intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07452250, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2026.

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