Ferumoxytol Enhanced Hyperfine Low Field Strength MRI

NCT04721262 | Completed DMC FDA Device

• 1 other identifier: 842634
• Study Type: observational
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this pilot study is to evaluate the feasibility of using Ferumoxytol as a contrast agent on a low field strength, portable magnetic resonance imaging (MRI) system. Participants receiving Ferumoxytol as part of routine clinical care for iron deficiency anemia will be recruited and scanned on the Hyperfine MRI system before and after their clinically scheduled intravenous infusion. Resultant images will be compared to assess signal intensity changes generated by the presence of Feromoxytol.

Conditions

Anemia, Hemolytic

Keywords

Anemia; Infusion; Ferumoxytol; Feraheme

Outcome Measures

Primary Outcomes (1)

• Contrast enhancement

  Changes in MRI signal intensity (contrast enhancement) produced by the presence of the Ferumoxytol contrast agent will be quantified by co-registering brain MRI studies obtained before and after administration of Ferumoxytol and determining the ratio of signal intensity values between the two sets of images (post-Ferumoxytol/pre-Ferumoxytol) in regions of interest placed separately over brain parenchyma or vascular structures. Based on the magnetic properties of Ferumoxytol, this contrast ratio is expected to be greater than one for T1-weighted scans and less than one for T2- or T2\*-weighted scans.

  2 thirty-five minute scans

Study Arms (1)

Patients prescribed Ferumoxytol for iron deficiency anemia

Patients with iron deficiency anemia are commonly prescribed Ferumoxytol periodically as part of their standard clinical care. Multiple studies have characterized the efficacy and safety of Ferumoxytol in the treatment of iron deficiency anemia. Patients prescribed Ferumoxytol for iron-deficiency anemia typically include otherwise healthy women with heavy menstrual periods, patients with inflammatory bowel disease, and patients with chronic kidney disease. Such patients make ideal candidates for characterizing the effects of Ferumoxytol on novel imaging devices by obviating a medically unnecessary injection of the contrast agent.

Device: Hyperfine Portable MRI

Interventions

Hyperfine Portable MRI DEVICE

The Hyperfine device is a newly developed MRI unit that has multiple potential advantages over standard CT or MRI including portability, easier upkeep, open design, and ease of use. Unlike CT, the Hyperfine device does not use moving parts or X-rays to generate images. Unlike routine MRI, the Hyperfine device uses two permanent magnets with open space between and around them, rather than a super-cooled superconducting magnetic tube. In contrast to CT and routine MRI, the device can be wheeled from place to place and moved into position with the patient remaining on a gurney or hospital bed. Relative to routine MRI, the device uses a very low magnetic field strength of 64 mT compared to 1.5 T or 3 T, making it safer for patients or environments with medical devices having metallic components.

Patients prescribed Ferumoxytol for iron deficiency anemia

Eligibility Criteria

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

Study Population

Subjects referred from the Hematology Oncology Department, scheduled to receive an intravenous infusion of Ferumoxytol as part of their standard of care (SOC) treatment for iron deficiency anemia will receive one Hyperfine MRI scan of the brain prior to their infusion and one Hyperfine MRI scan of the brain after their infusion.

You may qualify if:

• Age 18 years or older
• Prescribed Ferumoxytol for iron deficiency anemia
• Informed consent obtained from patient or a legally authorized representative

You may not qualify if:

• Contraindications to routine 1.5 T MRI evaluation, including:
• Electrical implants such as cardiac pacemakers or perfusion pumps
• Ferromagnetic implants such as aneurysm clips, surgical clips, prostheses, artificial hearts or heart valves with steel parts, metal fragments, shrapnel, tattoos near the eye, steel implants, or other irremovable ferromagnetic objects
• History of uncontrolled seizures
• Claustrophobia
• Weight greater than or equal to 400 lbs (181.4 kg)
• Pregnancy
• Inability or suspected inability to comply with the study procedures

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Anemia, Hemolytic; Anemia

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Radiology

Study Record Dates

• First Submitted: November 2, 2020
• First Posted: January 22, 2021
• Study Start: November 9, 2020
• Primary Completion: August 29, 2022
• Study Completion: August 29, 2022
• Last Updated: December 20, 2022

Record last verified: 2022-12

Locations

US (1)