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Completed
NCT04436068
Hyperfine Portable MRI in Hydrocephalus and Other Conditions Prompting Outpatient Brain Imaging
Conditions: Hydrocephalus, Neurological Disorder
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 100
Sponsor: University of Pennsylvania
Location: University of Pennsylvania Philadelphia Pennsylvania
Summary
Participants with known or suspected hydrocephalus will receive brain scans using the Hyperfine, low field strength, portable, magnetic resonance imaging (MRI) system in addition to their scheduled outpatient standard of care clinical computed tomography (CT) or MRI scan. The purpose of this pilot study is to evaluate the feasibility and acceptability of using the Hyperfine system in an outpatient setting and to compare its diagnostic performance to standard clinical imaging.
Outpatients with other known or suspected neurological disorders or conditions prompting routine clinical brain imaging with MRI or CT will also be enrolled and the diagnostic performance of low field scans compared to that of the same day standard of care clinical imaging.
Eligibility Criteria
Inclusion Criteria:
* Age 18 years or older
* Suspected or confirmed diagnosis of hydrocephalus from Penn referring physician
* Other suspected or confirmed neurological disorder from Penn referring physician
* Routine clinical CT or MRI of the brain scheduled/obtained on the same day as Hyperfine imaging.
* Informed consent obtained from patient or legally authorized representative
Exclusion Criteria:
* Contraindications to routine 1.5T MRI evaluation, including electrical implants such as cardiac pacemakers or perfusion pumps, ferromagnetic implants such as aneurysm clips, surgical clips, protheses, 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 400lbs (181.4kg)
* Pregnancy
* Inability or suspected inability to comply with the study procedures
Source: ClinicalTrials.gov (NCT04436068). StuddyBuddy aggregates publicly available trial information.