Hyperfine MRI for Detecting Brain Injury in Pediatric ECMO Patients

Overseen By Maura Sien, MSML, CCRC

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Children's Mercy Hospital Kansas City

Disqualifiers: Pregnancy, Active implants, Metal in eye, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 7 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 2 weeks

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a portable MRI, the Hyperfine Swoop System, to detect brain injuries in children requiring ECMO, a life-support treatment for severe heart or lung issues. The goal is to determine the prevalence and progression of these injuries compared to regular hospital scans. The trial seeks children in intensive care who are at high risk or currently on ECMO, including those undergoing heart surgery or facing severe respiratory or cardiac problems. As an unphased trial, it provides a unique opportunity to enhance understanding of brain injuries in critically ill children.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What prior data suggests that the Hyperfine MRI is safe for pediatric ECMO patients?

Research has shown that the Hyperfine MRI system, also known as the Swoop Portable MR Imaging System, is safe for both adults and children. In studies with patients using ECMO (a machine that assists with breathing and heart function), this portable MRI revealed no major safety issues. Another study confirmed that this ultra-low-field portable MRI is safe for children on ECMO. No serious problems were reported in these groups, indicating that the device is well-tolerated and does not cause harm during use. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Hyperfine portable MRI is unique because it provides a way to detect brain injuries in pediatric ECMO patients without the need for traditional, bulky MRI machines. Unlike standard MRIs, which require transferring patients to dedicated imaging facilities, this portable MRI can be used right at the bedside. Researchers are excited about this technology because it offers quicker and more convenient brain scans, minimizing the risks associated with moving critically ill patients. Additionally, the ability to perform frequent scans could lead to more timely and tailored treatment decisions.

What evidence suggests that the Hyperfine MRI is effective for detecting brain injury in pediatric ECMO patients?

This trial will use the Hyperfine MRI, specifically the portable version, to aid in the early detection of brain injuries in pediatric ECMO patients. Studies have shown that this system is crucial for children on ECMO, a life-support treatment, as it can detect issues like strokes or bleeding in the brain earlier and more accurately than traditional CT scans. Research indicates that the Hyperfine Swoop MRI system operates faster than regular MRIs, with scans taking about 2.5 hours instead of over 27 hours. This speed enables doctors to respond quickly to brain injuries. Overall, the Hyperfine MRI's ability to quickly and accurately identify brain problems can greatly benefit children receiving ECMO. ^{4 5 6 7 8}

Who Is on the Research Team?

Jessica Wallisch, MD

Principal Investigator

Children's Mercy Kansas City

Are You a Good Fit for This Trial?

This trial is for pediatric patients aged 0-17 years who are receiving ECMO support due to conditions like brain injury from lack of oxygen, stroke, or trauma. They must be in the Pediatric Intensive Care Unit, Cardiac Intensive Care Unit, or Neonatal Intensive Care Unit.

Inclusion Criteria

Undergoing venovenous or venoarterial ECMO

My child is in the ICU, CICU, or NICU.

I am 17 years old or younger.

Exclusion Criteria

I have worked as a welder, metal worker, or have had a metal injury.

Active implants such as pacemaker, implanted defibrillator, implanted insulin pump, deep brain stimulator, vagus nerve stimulator, cochlear implant, programmable shunt

Metal-containing tattoos or permanent make-up on head or neck

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Perform bedside MRI in pediatric ECMO patients within 24 hours of cannulation and weekly until decannulation

2 weeks

Multiple visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Hyperfine

Trial Overview The study aims to use a portable MRI device called Hyperfine to detect acute brain injuries (ABI) in children on ECMO support. It will track how often and when these injuries occur during treatment compared with routine care imaging.

How Is the Trial Designed?

Group I: Portable MRI Arm Experimental Treatment 1 Intervention

All subjects enrolled will be assigned to Arm 1

Hyperfine is already approved in United States, European Union, Canada, United Kingdom for the following indications:

Approved in United States as Swoop Portable MR Imaging System for:

• Brain imaging

Approved in European Union as Swoop Portable MR Imaging System for:

• Brain imaging

Approved in Canada as Swoop Portable MR Imaging System for:

• Brain imaging

Approved in United Kingdom as Swoop Portable MR Imaging System for:

• Brain imaging

Who Is Running the Clinical Trial?

Children's Mercy Hospital Kansas City

Lead Sponsor

Trials

261

Recruited

941,000+

Published Research Related to This Trial

In a study of 81 neonates treated with extracorporeal membrane oxygenation (ECMO), those on veno-arterial (VA) ECMO experienced more severe brain injuries compared to those on veno-venous ECMO, highlighting the risks associated with different ECMO types.

The duration of ECMO treatment was significantly linked to the severity of brain injury, with a notable increase in risk for severe injury in patients on ECMO for more than 210 hours, although improvements in care appear to be reducing the overall incidence of brain injury over time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risk Factors for Brain Injury in Newborns Treated with Extracorporeal Membrane Oxygenation. Melbourne, L., Wien, MA., Whitehead, MT., et al.[2022]

In a pilot study of 29 neonatal and pediatric patients supported by ECMO, 34% exhibited developmental delays, with a significant correlation between MRI abnormalities and these delays, particularly in newborns.

Younger patients placed on ECMO had a higher risk of impaired neurodevelopmental outcomes, suggesting that post-ECMO MRI assessments should be standard practice to predict and improve long-term developmental results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neurodevelopmental Outcomes in Extracorporeal Membrane Oxygenation Patients: A Pilot Study. Dhar, AV., Scott, S., Anton-Martin, P., et al.[2021]

Bedside low-field MRI has been successfully performed on four pediatric patients undergoing extracorporeal life support (ECLS), demonstrating its safety and feasibility in unstable conditions.

This advancement allows for high-quality neuroimaging that can inform treatment decisions, potentially leading to better outcomes for critically ill pediatric patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of bedside portable MRI in neonates and children during ECLS. Sabir, H., Kipfmueller, F., Bagci, S., et al.[2023]

In a study of 50 neonates who underwent MRI after ECMO, MRI detected abnormalities in 62% of cases, significantly more than the 24% detected by head ultrasound (HUS), indicating that MRI may be a more effective imaging method post-ECMO.

Despite the higher detection rate of abnormalities with MRI, neither MRI nor HUS findings were linked to early neurodevelopmental outcomes, with the need for supplemental tube feeds at discharge being the strongest predictor of neurological impairment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Utility of neuroradiographic imaging in predicting outcomes after neonatal extracorporeal membrane oxygenation. Rollins, MD., Yoder, BA., Moore, KR., et al.[2012]

A study involving 60 infants in a neonatal intensive care unit (NICU) demonstrated that point-of-care 1-Tesla MRI can effectively identify significant intracranial pathologies, such as ischemic lesions and microhemorrhages, which are crucial for timely medical intervention.

While the 1-Tesla MRI had limitations compared to higher-field strength MRIs (like 3-Tesla), it still provided valuable diagnostic information that was not visible on transcranial ultrasound, highlighting its potential utility in NICU settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A 1-Tesla MRI system for dedicated brain imaging in the neonatal intensive care unit. Berson, ER., Mozayan, A., Peterec, S., et al.[2023]

This study is the first to demonstrate that MRI can be safely performed during extracorporeal membrane oxygenation (ECMO) without adversely affecting the ECMO system, as shown in a healthy pig model.

MRI provides high-quality anatomical and functional images of the brain and thoracic vessels, suggesting its potential for early diagnosis of cerebral complications and for research on brain perfusion during ECMO.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

MRI of the brain and thorax during extracorporeal membrane oxygenation: preliminary report from a pig model. Lidegran, MK., Frenckner, BP., Mosskin, M., et al.[2016]

Point-of-care (POC) brain MRI is safe for use in adult patients supported by veno-arterial extracorporeal membrane oxygenation (VA-ECMO) and an intra-aortic balloon pump (IABP), with no adverse effects observed during testing.

In a small case series of three patients, POC brain MRI successfully identified multiple signal abnormalities that correlated with head CT results, suggesting it could be an effective tool for early detection of acute brain injury in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of Bedside Portable Low-Field Brain MRI in ECMO Patients Supported on Intra-Aortic Balloon Pump. Wilcox, C., Acton, M., Rando, H., et al.[2023]

In a study involving 14 neonates, 94% of portable MRI examinations were successfully completed without significant artefacts, indicating that this technology can be safely used in the NICU setting.

While portable MRI was effective in detecting significant intracranial pathologies, it missed some subtle abnormalities, suggesting that while it is a promising tool, it may not fully replace standard MRI examinations for all diagnostic needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of and experience using a portable MRI scanner in the neonatal intensive care unit. Sien, ME., Robinson, AL., Hu, HH., et al.[2022]

In a study of 81 neonates treated with extracorporeal membrane oxygenation (ECMO), 46% showed brain injury on MR imaging, with the most common injuries occurring in the frontal and temporoparietal white matter.

The study found that while there were more brain injuries in neonates treated with venoarterial ECMO (49%) compared to venovenous ECMO (29%), the overall pattern of injury was similar between the two treatment methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patterns of Brain Injury in Newborns Treated with Extracorporeal Membrane Oxygenation. Wien, MA., Whitehead, MT., Bulas, D., et al.[2021]

MRI can effectively identify lung damage in preterm children, both with and without bronchopulmonary dysplasia (BPD), showing significant differences in lung disease percentage among groups, with BPD children having 9.1% diseased lung compared to 3.4% in those without BPD and 0.4% in healthy volunteers.

The study found that MRI results correlated well with lung function tests (spirometry), indicating that MRI is a safe and sensitive method for assessing lung health in preterm children without exposing them to ionizing radiation or anesthesia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lung structure and function on MRI in preterm born school children with and without BPD: A feasibility study. Elders, BBLJ., Tiddens, HAWM., Pijnenburg, MWH., et al.[2023]

Citations

1. withpower.com withpower.com/trial/phase-brain-injuries-traumatic-6-2024-40f30

Hyperfine MRI for Detecting Brain Injury in Pediatric ECMO ... The primary objective is to characterize the prevalence and type of ABI following cannulation for pediatric patients who require ECMO support.

2. hyperfinemri.com hyperfinemri.com/about/news/press-release-observational-study-finds-that-hyperfine-inc-portable-mr-brain-imaging-system-assists-clinicians-in-early-detection-of-acute-brain-injury-in-ecmo-patients

Portable MR Brain Imaging System and ABI in ECMO ... This study signals the potential benefit of portable MR brain imaging over conventional CT scans during ECMO, especially in detecting early ischemic injuries.

3. investors.hyperfine.io investors.hyperfine.io/node/8911/pdf

Hyperfine Swoop® Portable MR Imaging® System Utilized ... Hyperfine Swoop® Portable MR Imaging® System Utilized in Multicenter SAFE MRI ECMO ... ECMO and investigated the frequency of acute brain injury ( ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10576557/

Current role of portable MRI in diagnosis of acute ... Benefits of pMRI include timely and accurate detection of major acute neurological pathologies such as stroke and intracranial hemorrhage.

5. clinicaltrialsarena.com clinicaltrialsarena.com/news/hyperfine-swoop-mri-system-trumps-standard-mris-in-interim-study/

Hyperfine's Swoop MRI system trumps standard MRIs in ... Hyperfine revealed data that the Swoop system outperformed conventional MRI in speed, with a median time-to-scan of 2.5 hours compared to 27.7 hours.

6. hyperfinemri.com hyperfinemri.com/about/news/press-release-hyperfine-swoop-portable-mr-imaging-system-utilized-in-multicenter-safe-mri-ecmo-study-published-in-the-september-29th-issue-of-circulation

Study Utilizes Portable MRI for ECMO Patients The SAFE MRI ECMO study evaluated the use of ultra-low field portable MR imaging on ICU patients undergoing extracorporeal membrane oxygenation (ECMO)

7. ahajournals.org ahajournals.org/doi/10.1161/CIRCULATIONAHA.124.069187

Results From the Multicenter SAFE MRI ECMO Study Ultra–low-field (0.064-T) portable magnetic resonance imaging is safe in patients on extracorporeal membrane oxygenation support across ...

8. medrxiv.org medrxiv.org/content/10.1101/2025.05.12.25327194v1

Ultralow-field portable MRI feasibility and safety in pediatric ... pMRI is safe and feasible in pediatric ECMO with no clinically relevant complications seen in our cohort.