Diagnostic Performance of a Novel Ferumoxytol-Enhanced Magnetic Resonance Angiography/ Venography on Panvascular Disease

September 24, 2024 updated by: Chunjian Li, The First Affiliated Hospital with Nanjing Medical University

Diagnostic Performance of a Novel Ferumoxytol-Enhanced Coronary Magnetic Resonance Angiography/ Venography on Panvascular Disease: a Single-center Clinical Study.

The goal of this observational study is to test the diagnostic performance of ferumoxytol-enhanced magnetic resonance angiography/ venography（FE-MRA/MRV） on panvascular disease. The main questions it aims to answer are:

  1. How about the imaging quality of FE-MRA/MRV for panvascular disease?
  2. What is the diagnostic performance of FE-MRA/MRV for panvascular disease?

Participants will be divided into two groups based on their symptoms, body signs or laboratory examinations. Participants who suspected with multisite atherosclerotic diseases like coronary artery disease accompany with renal artery stenosis or peripheral arterial disease will be recruited in multisite artery disease (MAD) group. While participants who suspected with venous thromboembolism (VTE) like pulmonary embolism or deep vein thrombosis will be recruited in VTE group. Participants in MAD group will take both FE-MRA and percutaneous selective angiography measurements of coronary, renal, or lower extremity artery, while participant in VTE group need to do pulmonary artery FE-MRA and computed tomography pulmonary angiography (CTPA), lower extremity vein FE-MRV and ultrasonography.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Panvascular disease refers to multi-site vascular disease, presenting as multi-site atherosclerotic disease and venous thromboembolism. There is no gold standard test for panvascular disease up to now. Clinical tests of the suspected population are often carried out by parts and times, and there is no one-stop, panoramic examination on panvascular disease.

Ferumoxytol is a novel and safe MRI contrast agent with an intravascular half-life of approximately 15 hours, enabling simultaneous scanning of multiple sites. At this background, our study intends to investigate the diagnostic efficacy of FE-MRA/MRV in panvascular diseases.

In this study, we plan to enroll 200 patients with suspected panvascular disease. Patients with suspected coronary artery disease, renal artery stenosis, or lower extremity arterial disease will be included in the MAD group, and patients with suspected pulmonary artery embolism and lower extremity venous embolism will be included in the VTE group.

In the MAD group, patients will take both FE-MRA and percutaneous selective angiography of coronary, renal, or lower extremity artery. We will record the FE-MRA image quality score, signal to noise ratio(SNR), compare signal-to-noise ratio（CNR）, whether the coronary, renal, and lower extremity arteries have stenosis greater than 50%, and whether the below-knee arteries are occluded. In the VTE group, patients need to do pulmonary artery FE-MRA and computed tomography pulmonary angiography (CTPA), lower extremity vein FE-MRV and ultrasonography. We will record the image quality scores of FE-MRA of the pulmonary arteries, the FE-MRV the lower extremities, SNR, CNR, the presence of pulmonary embolism or deep vein thrombosis.

The sensitivity, specificity, positive predictive value, and negative predictive value of FE-MRA for the diagnosis of arteries stenosis >50% will be evaluated by using percutaneous selective angiography as the gold standard and generating subject operating characteristic (ROC) curves. And the sensitivity, specificity, positive predictive value, and negative predictive value of FE-MRA/MRV for the diagnosis of thrombosis in the pulmonary artery or lower extremities will be evaluated by generating ROC curves by using CTPA and venous ultrasound as the reference.

Study Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

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

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210000
        • Recruiting
        • First Affiliated Hospital of Nanjing Medical University
        • Contact:

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

This study adopts a continuous enrollment method. It is estimated that 200 suspected pan-vascular disease patients will be enrolled within the study period.

Description

Inclusion Criteria:

  1. Age 18 to 85 years;

  2. Those with suspected multi-site atherosclerotic vascular disease (MAD) (fulfilling both a), and at least two of b), c), and d)):

    1. have at least 1 risk factor for atherosclerosis (hypertension, diabetes mellitus, hyperlipidemia, smoking, and obesity);
    2. Those with suspected coronary atherosclerotic cardiovascular disease: angina symptoms, ST-T changes on ECG;
    3. those with suspected atherosclerotic renal artery stenosis: periumbilical vascular murmur, intractable hypertension, renal insufficiency difficult to explain by other causes;
    4. Those with suspected atherosclerotic lower extremity peripheral arterial disease: intermittent claudication, diminished or absent dorsalis pedis arterial pulses.

  3. Those with suspected venous thromboembolism (VTE) (fulfill at least one of a) and b)):

    1. Those with suspected DVT: swelling and pain in the lower extremities;
    2. Those with suspected PE: simplified Wells score ≥ 1.
  4. Patients sign an informed consent form.

Exclusion Criteria:

  1. Those who are allergic to iodine contrast media or have a history of allergy or hypersensitivity to iron or dextrose;
  2. Those who are unable to undergo MRI due to psychological (e.g., suffering from claustrophobia syndrome) or physical reasons (e.g., retention of metallic objects in the body);
  3. Those with terminal illness (e.g., suffering from malignant tumors) or with a life expectancy of <1 year;
  4. Liver insufficiency (alanine aminotransferase > 3 times the upper limit of normal value);
  5. Renal insufficiency (eGFR <30mL/min/1.73cm2);
  6. Hyperthyroidism;
  7. Those with hemodynamic instability;
  8. Pregnant and lactating women;
  9. Persons with hearing limitations;
  10. Persons with cardiac function class III-IV;
  11. Persons on other oral or intravenous iron supplements;
  12. Patients with ferrous hemosiderin deposition or hemochromatosis;
  13. Patients with acute coronary syndromes;
  14. Any other person who, in the opinion of the investigator, should not participate in this study.

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
Multisite Artery Disease (MAD) Group
Participants in MAD group mean these patients are suspected with multisite artery disease, like coronary artery disease accompany with renal artery stenosis or lower extremity atherosclerosis.
Diagnostic test: Ferumoxytol Enhanced Magnetic Resonance Angiography（ FE-MRA）；Coronary/Renal /Lower artery Arteriography
When the patient is suspected with multisite artery disease, FE-MRA and angiography will be performed according to the patient's clinical manifestation. For example, when the patient is suspected with coronary artery disease, coronary FE-MRA and angiography will be performed; when the patient is suspected with renal artery stenosis, renal artery FE-MRA and angiography will be performed; and when the patient is suspected with the lower extremity artery occlusion, the lower extremity artery FE-MRA and angiography will be performed.
Venous Thromboembolism （VTE）Group
Participants in VTE group mean these patients are suspected with deep vein thrombosis or pulmonary embolism.
Diagnostic test: Ferumoxytol Enhanced Magnetic Resonance Venography（ FE-MRV）, Computed Tomography Pulmonary Angiography, Ultrasound for Lower Extremity Deep Vein.
When the patient is suspected with venous thromboembolism, the lower extremity vein FE-MRV, pulmonary FE-MRA and ultrasound for lower extremity deep vein as well as computed tomography pulmonary angiography will be taken to ensure whether the patient with thrombus or not.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the degree of coronary/ renal/lower extremity artery stenosis
Time Frame: 1 week
Degree of artery stenosis assessed by FE-MRA and percutaneous selective angiography.
1 week
Deep Vein Thrombosis
Time Frame: 1 week
FE-MRV and ultrasound for lower extremity deep vein will be taken to evaluate whether there is deep vein thrombosis or not.
1 week
Pulmonary Embolism
Time Frame: 1 week
FE-MRA and computed tomography pulmonary angiography will be taken to evaluate whether there is pulmonary embolism or not.
1 week
Image quality of FE-MRA/MRV
Time Frame: 1 week

The image quality will be assessed by a 4-point scale:

  1. poor (vessel barely evident or noisy image);
  2. moderate (vessel visible but diagnostic confidence low);
  3. good (vessel adequately visualized and diagnostic quality image);
  4. excellent (vessel clearly depicted)
1 week
signal-to-noise ratio （SNR）
Time Frame: 1 week
An indicator represents for image quality.
1 week
contrast-to-noise ratio (CNR)
Time Frame: 1 week
An indicator represents for image quality.
1 week
below-knee artery occlusion
Time Frame: 1 week
Whether below-knee arteries occlusion or not assessed by FE-MRA and percutaneous selective angiography .
1 week

Collaborators and Investigators

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

Sponsor

The First Affiliated Hospital with Nanjing Medical University

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 (Actual)

February 23, 2024

Primary Completion (Estimated)

January 30, 2025

Study Completion (Estimated)

January 30, 2025

Study Registration Dates

First Submitted

November 13, 2023

First Submitted That Met QC Criteria

November 13, 2023

First Posted (Actual)

November 18, 2023

Study Record Updates

Last Update Posted (Actual)

September 26, 2024

Last Update Submitted That Met QC Criteria

September 24, 2024

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 027

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

product manufactured in and exported from the U.S.

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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