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AtherosclerosisNCT06551805

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

An observational study of Atherosclerosis, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School 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

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Atherosclerosis
What is being tested?
Safety assessment of Ferumoxytol. and Assessment of the diagnostic value of Ferumoxytol for MR angiography.
Type of treatment
Injection or infusion
How many people
100 participants
Where
1 siteChina
Study dates
12 Aug 2024to 30 Dec 2026
Phase
Observational
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

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.

Who may be able to join

None listed.

Who cannot join

  • 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.

Trial locations and contacts

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

China1 site, 1 recruiting
  • Department of Radiology, the Affiliated Drum Tower Hospital of Nanjing University

    Nanjing, Jiangsu, 210008

    Bing Zhang, MD, PhD, 86-15851803070, zhangbing_nanjing@vip.163.com

    Bing Zhang, MD, PhD

    Recruiting

Other trials in China

About this study

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.

Read the 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.

Conditions
Atherosclerosis
Being tested
Safety assessment of Ferumoxytol., Assessment of the diagnostic value of Ferumoxytol for MR angiography.
Medical subject headings
Atherosclerosis

What participants receive

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

  • Safety assessment of Ferumoxytol.Drug

    Also called Superparamagnetic iron oxide

    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.

  • Assessment of the diagnostic value of Ferumoxytol for MR angiography.Drug

    Also called Superparamagnetic iron oxide

    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.

Study groups in NCT06551805
Study groupRoleWhat they receive
Safety assessment and the diagnostic value of Ferumoxytol.Drug Name: Ferumoxytol Dosage Form: Injection Dosage: 3 mg/kg Administration Frequency: Single intravenous injection
Receives: Drug: Safety assessment of Ferumoxytol.; Drug: Assessment of the diagnostic value of Ferumoxytol for MR angiography.

What is being measured

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

  1. Ferumoxytol demonstrates a favorable safety profile in human subjects.

    safe

    Measured: 2023.10-2026.12

  2. Ferumoxytol exhibits diagnostic efficacy for MR angiography.

    diagnostic efficacy

    Measured: 2023.10-2026.12

Timeline

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

  1. First posted13 Aug 2024
  2. Study start12 Aug 2024 (estimated)
  3. Primary completion30 Sep 2026 (estimated)
  4. Study completion30 Dec 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
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06551805
Sponsor's protocol ID
2023-178-05
Status last verified
Aug 2023
First submitted
30 Jun 2023
Last updated
13 Aug 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Fraum TJ, Ludwig DR, Bashir MR, Fowler KJ. Gadolinium-based contrast agents: A comprehensive risk assessment. J Magn Reson Imaging. 2017 Aug;46(2):338-353. doi: 10.1002/jmri.25625. Epub 2017 Jan 13.

    PubMed 28083913
  • McDonald RJ, Levine D, Weinreb J, Kanal E, Davenport MS, Ellis JH, Jacobs PM, Lenkinski RE, Maravilla KR, Prince MR, Rowley HA, Tweedle MF, Kressel HY. Gadolinium Retention: A Research Roadmap from the 2018 NIH/ACR/RSNA Workshop on Gadolinium Chelates. Radiology. 2018 Nov;289(2):517-534. doi: 10.1148/radiol.2018181151. Epub 2018 Sep 11.

    PubMed 30204075
  • Blomqvist L, Nordberg GF, Nurchi VM, Aaseth JO. Gadolinium in Medical Imaging-Usefulness, Toxic Reactions and Possible Countermeasures-A Review. Biomolecules. 2022 May 24;12(6):742. doi: 10.3390/biom12060742.

    PubMed 35740867
  • Idee JM, Port M, Robic C, Medina C, Sabatou M, Corot C. Role of thermodynamic and kinetic parameters in gadolinium chelate stability. J Magn Reson Imaging. 2009 Dec;30(6):1249-58. doi: 10.1002/jmri.21967.

    PubMed 19938037
  • Kanda T, Ishii K, Kawaguchi H, Kitajima K, Takenaka D. High signal intensity in the dentate nucleus and globus pallidus on unenhanced T1-weighted MR images: relationship with increasing cumulative dose of a gadolinium-based contrast material. Radiology. 2014 Mar;270(3):834-41. doi: 10.1148/radiol.13131669. Epub 2013 Dec 7.

    PubMed 24475844
  • Roberts DR, Holden KR. Progressive increase of T1 signal intensity in the dentate nucleus and globus pallidus on unenhanced T1-weighted MR images in the pediatric brain exposed to multiple doses of gadolinium contrast. Brain Dev. 2016 Mar;38(3):331-6. doi: 10.1016/j.braindev.2015.08.009. Epub 2015 Sep 4.

    PubMed 26345358
  • Miller JH, Hu HH, Pokorney A, Cornejo P, Towbin R. MRI Brain Signal Intensity Changes of a Child During the Course of 35 Gadolinium Contrast Examinations. Pediatrics. 2015 Dec;136(6):e1637-40. doi: 10.1542/peds.2015-2222. Epub 2015 Nov 16.

    PubMed 26574593
  • Muehe AM, Feng D, von Eyben R, Luna-Fineman S, Link MP, Muthig T, Huddleston AE, Neuwelt EA, Daldrup-Link HE. Safety Report of Ferumoxytol for Magnetic Resonance Imaging in Children and Young Adults. Invest Radiol. 2016 Apr;51(4):221-227. doi: 10.1097/RLI.0000000000000230.

    PubMed 26656202
  • Spinowitz BS, Kausz AT, Baptista J, Noble SD, Sothinathan R, Bernardo MV, Brenner L, Pereira BJ. Ferumoxytol for treating iron deficiency anemia in CKD. J Am Soc Nephrol. 2008 Aug;19(8):1599-605. doi: 10.1681/ASN.2007101156. Epub 2008 Jun 4.

    PubMed 18525001
  • Hope MD, Hope TA, Zhu C, Faraji F, Haraldsson H, Ordovas KG, Saloner D. Vascular Imaging With Ferumoxytol as a Contrast Agent. AJR Am J Roentgenol. 2015 Sep;205(3):W366-73. doi: 10.2214/AJR.15.14534. Epub 2015 Jun 23.

    PubMed 26102308
  • Kooi ME, Cappendijk VC, Cleutjens KB, Kessels AG, Kitslaar PJ, Borgers M, Frederik PM, Daemen MJ, van Engelshoven JM. Accumulation of ultrasmall superparamagnetic particles of iron oxide in human atherosclerotic plaques can be detected by in vivo magnetic resonance imaging. Circulation. 2003 May 20;107(19):2453-8. doi: 10.1161/01.CIR.0000068315.98705.CC. Epub 2003 Apr 28.

    PubMed 12719280
  • Bashir MR, Bhatti L, Marin D, Nelson RC. Emerging applications for ferumoxytol as a contrast agent in MRI. J Magn Reson Imaging. 2015 Apr;41(4):884-98. doi: 10.1002/jmri.24691. Epub 2014 Jun 30.

    PubMed 24974785
  • Stephen ZR, Kievit FM, Zhang M. Magnetite Nanoparticles for Medical MR Imaging. Mater Today (Kidlington). 2011 Jul;14(7-8):330-338. doi: 10.1016/S1369-7021(11)70163-8.

    PubMed 22389583
  • Jeon M, Halbert MV, Stephen ZR, Zhang M. Iron Oxide Nanoparticles as T1 Contrast Agents for Magnetic Resonance Imaging: Fundamentals, Challenges, Applications, and Prospectives. Adv Mater. 2021 Jun;33(23):e1906539. doi: 10.1002/adma.201906539. Epub 2020 Jun 4.

    PubMed 32495404
  • Blockley NP, Jiang L, Gardener AG, Ludman CN, Francis ST, Gowland PA. Field strength dependence of R1 and R2* relaxivities of human whole blood to ProHance, Vasovist, and deoxyhemoglobin. Magn Reson Med. 2008 Dec;60(6):1313-20. doi: 10.1002/mrm.21792.

    PubMed 19030165

Questions about this trial

What is this clinical trial studying?

An observational study of Atherosclerosis, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School 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 0 inclusion and 3 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 13 Aug 2024. 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.

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 Jing Liang (18262638917, liangjingxyz@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Ferumoxytol demonstrates a favorable safety profile in human subjects. (time frame: 2023.10-2026.12). The study lists 2 primary outcomes in all. 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 NCT06551805, which also lists 23 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 13 Aug 2024; AzTrials last refreshed its copy on 8 Nov 2026.

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