Clinical Research Protocol of Ferumoxytol for Magnetic Resonance Enhancement Imaging in Patients With Atherosclerosis.

August 11, 2024 updated by: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
We are preparing to initiate a clinical trial involving Ferumoxytol for magnetic resonance-enhanced imaging in patients with atherosclerosis. The aim of this study is to assess the safety and effectiveness of Ferumoxytol for magnetic resonance angiography in patients with atherosclerosis.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

In this study, the safety of Ferumoxytol as an MR imaging contrast agent will be assessed by monitoring vital signs and laboratory parameters such as complete blood count, urinalysis, and liver and kidney function tests before and after administration of Ferumoxytol. Following the injection, all patients will undergo two MRI scans at different time intervals, ranging from 0 to 15 hours and from 24 to 48 hours. Within one week prior to the injection, patients will undergo standard laboratory tests as part of their routine clinical assessment, and the pre-administration lab results will be documented.

This study will prospectively enroll patients with atherosclerosis, and Ferumoxytol-enhanced MRA imaging will be performed on all patients to investigate the diagnostic utility of Ferumoxytol as an MR imaging contrast agent.

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210008
        • Recruiting
        • Department of Radiology, the Affiliated Drum Tower Hospital of Nanjing University
        • Contact:
        • Principal Investigator:
          • Bing Zhang, MD, PhD
        • Sub-Investigator:
          • Wen Zhang, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

  1. CKD patients aged ≥18 years.
  2. Presence of atherosclerosis in the head and neck vessels and/or coronary arteries and/or renal arteries, as indicated by other evidence.

Description

Inclusion criteria: Patients aged 18 years and older with atherosclerosis.

Exclusion criteria:

Individuals with a history of allergy or hypersensitivity to iron or dextran. Patients currently receiving oral or intravenous iron therapy. Patients with hemosiderosis or hemochromatosis. Patients with a history of allergic reactions to intravenous iron products or any iron overload-related conditions.

Individuals who are unable to undergo magnetic resonance imaging (MRI) due to psychological reasons (such as claustrophobia) or physical reasons (such as the presence of non-compatible metallic objects in the body).

Patients with end-stage diseases or life expectancy less than 1 year. Pregnant women. Any other individuals deemed unsuitable for inclusion by the investigator.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Safety assessment and the diagnostic value of Ferumoxytol.
Drug Name: Ferumoxytol Dosage Form: Injection Dosage: 3 mg/kg Administration Frequency: Single intravenous injection
Drug: Safety assessment of Ferumoxytol.
Observe the injection site for skin invagination, rash, or urticaria during injection. Patients and their relatives were asked about any subjective adverse events before, during, and after drug injection, and all adverse events were recorded on the case report forms, and adverse events were scored according to the Common Terminology Criteria for Adverse Events (CTCAE) from Grade 1 "mild" to Grade 5 "death", Observe the vital signs of patients. Patients undergoing MRI underwent electrocardiogram (ECG) monitoring before and within 60 minutes after ferumoxytol administration, specifically including: biochemical panel, iron metabolism, liver and kidney function, cytokines, blood routine, urine routine, 24-hour urine volume, glycosylated hemoglobin and so on. All patients received a total of 3 blood and urine collections at 7 days before injection, 48 hours after injection, 1month to 3months after injection.
Other Names:
  • Superparamagnetic iron oxide
Drug: Assessment of the diagnostic value of Ferumoxytol for MR angiography.
steady-state, high-spatial-resolution, three-dimensional fast low-angle shot acquisition technique, T2W-MDIR imaging, polysaccharide superparamagnetic iron oxide injection enhanced T1W and T2W, T2* mapping, and Steady state free precession sequence, T2 weighted black blood sequence, T2 preparation single shot steady state free precession sequence, T2* weighted multi-echo/gradient echo sequence, polysaccharide superparamagnetic iron oxide injection enhanced imaging, Breath-triggered Transverse 3D Balance-Vortex Field Echo (b-TFE) Magnetic Resonance Angiography, iMSDE-SPGR Sequence, 4D Flow MRI. the MRI anxiety questionnaire.
Other Names:
  • Superparamagnetic iron oxide

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ferumoxytol demonstrates a favorable safety profile in human subjects.
Time Frame: 2023.10-2026.12
safe
2023.10-2026.12
Ferumoxytol exhibits diagnostic efficacy for MR angiography.
Time Frame: 2023.10-2026.12
diagnostic efficacy
2023.10-2026.12

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
lower limb artery Image Acquisition
Time Frame: All patients underwent MRI after injection of polysaccharide superparamagnetic iron oxide injection.
atherosclerosis
All patients underwent MRI after injection of polysaccharide superparamagnetic iron oxide injection.
Adverse Events
Time Frame: Before, during, after injection
no adverse events
Before, during, after injection
Vital signs
Time Frame: Obtained before injection, 15, 30, 45, 60 minutes after injection and before and after the second MR scan.
safety
Obtained before injection, 15, 30, 45, 60 minutes after injection and before and after the second MR scan.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 12, 2024

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

December 30, 2026

Study Registration Dates

First Submitted

June 30, 2023

First Submitted That Met QC Criteria

August 11, 2024

First Posted (Actual)

August 13, 2024

Study Record Updates

Last Update Posted (Actual)

August 13, 2024

Last Update Submitted That Met QC Criteria

August 11, 2024

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-178-05

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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