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Ferumoxytol Enhanced Hyperfine Low Field Strength MRI

NCT04721262 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 2

Last updated 2022-12-20

No results posted yet for this study

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

Interventions

DEVICE

Hyperfine Portable MRI

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.

Sponsors & Collaborators

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-09
Primary Completion
2022-08-29
Completion
2022-08-29
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04721262 on ClinicalTrials.gov