Ferumoxytol Enhanced Magnetic Resonance Angiography in Chronic Kidney Disease

NCT02997046 | Completed

• 1 other identifier: GN16RE117
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Conventional vascular imaging techniques are often either contra-indicated in chronic kidney disease (CKD) patients due to their relative invasiveness, risks and cost. Computed tomography angiography (CTA) requires radiation and nephrotoxic iodinated contrast which may precipitate significant worsening of renal function and even prompt the need for institution of dialysis. Magnetic resonance angiography (MRA) using gadolinium-based contrast agents has been associated with the rare disease nephrogenic systemic fibrosis. Alternative imaging methods also have drawbacks: for example, this frail patient group has a higher risk of complications from conventional invasive catheter-based angiography, non-contrast-enhanced MRA allows visualization of smaller arteries but is less accurate for larger vascular structures, and ultrasound is often not appropriate for evaluation of the deep vessels of the abdomen and pelvis. Ferumoxytol is an ultrasmall superparamagnetic iron oxide particle encapsulated by a semisynthetic carbohydrate, which was initially developed as a magnetic resonance imaging (MRI) contrast agent in 2000. However, interest in ferumoxytol as a therapeutic agent for the treatment of iron deficiency anaemia in the setting of CKD eclipsed its use as MRI contrast agent. During the last decade, ferumoxytol has gained appeal as an MRI contrast agent in patients with estimated glomerular filtration rates \<30mL/min and there are reports in the literature for its safe use and utility in both adult and pediatric patients with CKD. Participants will be selected from those who have been referred for assessment prior to kidney transplant or prior to vascular access creation for haemodialysis and will be divided into three groups. The first group will include patients who will undergo a CTA of abdominal and aortoiliac vasculature as part of their preparation for potential kidney transplantation. The second and third groups will include patients who are having a fistula or a graft created for dialysis, respectively. These patients are routinely having US vascular mapping to visualise the blood vessels before a fistula or a graft is created. Additionally, patients included in the second and third groups are routinely having surveillance scans of their fistula or graft at 6 weeks following creation. Study participants undergoing standard imaging tests as part of their clinical care will also have ferumoxytol-enhanced MRA (FeMRA).

Conditions

Ferric Compounds; Magnetic Resonance Angiography; Vascular Grafting; Arteriovenous Fistula; Kidney Transplantation

Keywords

Ferumoxytol; MRI; fistula; graft; kidney transplant; angiography; arteriovenous

Outcome Measures

Primary Outcomes (1)

• Comparison of FeMRA with standard imaging techniques in assessment of vascular anatomy.

  Multiple cross sections of various vascular beds obtained with currently used imaging techniques will be compared with matched sections obtained with FeMRA in a blinded fashion. The emphasis is generally on imaging quality and diagnostic accuracy on identification of clinically significant anatomic characteristics or lesions.

  Baseline and week 6

Secondary Outcomes (4)

• Comparison of FeMRA with standard imaging techniques in identification of anatomical predictors of vascular access outcomes.

  Up to 2 years

• Association between cardiac function and fistula (or graft) outcomes assessed by FeMRA.

  Up to 2 years

• Effect of successful fistula (or graft) creation on cardiac function assessed by FeMRA.

  Week 6

• Utility of FeMRA in assessment of cardiac anatomy and function before listing for kidney transplantation.

  Baseline

Study Arms (3)

Pre-transplant assessment

* CTA abdominal and aortoiliac vasculature before transplantation * FeMRA abdominal and aortoiliac vasculature \& CMR before transplantation

Mapping & surveillance (for fistula)

* US vascular mapping before fistula creation * 6 week US fistula arm * FeMRA fistula arm/central veins \& CMR before fistula creation and at 6 weeks

Mapping & surveillance (for graft)

* US vascular mapping before graft creation * 6 week US graft arm * FeMRA fistula arm/central veins \& CMR before graft creation and at 6 weeks

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Planned surgical creation of an autogenous upper-extremity fistula or synthetic graft.
• AND Current treatment with maintenance haemodialysis or anticipated treatment with maintenance haemodialysis within 6 months after planned fistula or graft creation surgery.
• OR Planned imaging of abdominopelvic vasculature as part of pre-transplant assessment.
• Anticipated ability to comply with study procedures.
• Ability to provide informed consent.

You may not qualify if:

• Life expectancy ≤6 months.
• Frail, elderly patients with multiple or serious co-morbidities (doctor's discretion).
• Pregnancy, lactation or women of child-bearing potential not willing to use effective contraception for the duration of the study.
• Standard contra-indications to MRI and severe claustrophobia.
• History of allergic reaction to any intravenous iron product, known hypersensitivity to excipients, asthma, eczema, atopy, patients with immune or inflammatory conditions (e.g. systemic lupus, rheumatoid arthritis), any conditions associated with iron overload (e.g. haemochromatosis, chronic liver disease, or blood disorders requiring frequent blood transfusions), and known history of drug allergy.

Sponsors & Collaborators

• Sokratis Stoumpos: lead
• NHS Greater Glasgow and Clyde: collaborator

Study Sites (1)

NHS Greater Glasgow and Clyde

Glasgow, G12 8TA, United Kingdom

Location

Related Publications (1)

• Stoumpos S, Tan A, Hall Barrientos P, Stevenson K, Thomson PC, Kasthuri R, Radjenovic A, Kingsmore DB, Roditi G, Mark PB. Ferumoxytol MR Angiography versus Duplex US for Vascular Mapping before Arteriovenous Fistula Surgery for Hemodialysis. Radiology. 2020 Oct;297(1):214-222. doi: 10.1148/radiol.2020200069. Epub 2020 Jul 21.

  PMID: 32692301 DERIVED

MeSH Terms

Conditions

Arteriovenous Fistula; Fistula

Condition Hierarchy (Ancestors)

Arteriovenous Malformations; Vascular Malformations; Cardiovascular Abnormalities; Cardiovascular Diseases; Vascular Fistula; Vascular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: December 14, 2016
• First Posted: December 19, 2016
• Study Start: December 12, 2016
• Primary Completion: September 1, 2018
• Study Completion: September 1, 2018
• Last Updated: February 12, 2019

Record last verified: 2019-02

Locations

GB (1)