Hyperfine Portable MRI in Hydrocephalus
Keywords
Abstract
Description
Hydrocephalus is a medical condition in which an abnormal buildup of cerebrospinal fluid (CSF) causes the fluid-filled spaces of the brain, the ventricles, to become enlarged. Enlarged ventricles and increased intracranial pressure can cause headaches, dizziness, blurred vision, cognitive impairment, gait disturbances and in severe cases even brain herniation or death. A tube or shunt can be inserted into the ventricles to drain the CSF either outside the body temporarily or into the abdominal cavity for long-term treatment. Sometimes such shunts need to be adjusted or replaced if fluid re-accumulates. Medical imaging scans, either computer tomography (CT) or magnetic resonance imaging (MRI), are used to diagnose hydrocephalus in adults and children.
The purpose of this pilot study is to assess the performance of a newly developed, portable, low-cost MRI machine (Hyperfine MRI) in diagnosing and following patients with hydrocephalus in comparison to routine clinical CT or MRI. Outpatients with known or suspected hydrocephalus with or without ventricular shunts will be recruited to undergo Hyperfine MRI in conjunction with their routine clinical imaging. We will evaluate both the feasibility and acceptability of using the Hyperfine unit in the outpatient setting as well as the performance of Hyperfine MRI images in identifying hydrocephalus and other key brain imaging features relative to routine CT and MRI.
Dates
| Last Verified: | 05/31/2020 |
| First Submitted: | 06/09/2020 |
| Estimated Enrollment Submitted: | 06/14/2020 |
| First Posted: | 06/16/2020 |
| Last Update Submitted: | 06/14/2020 |
| Last Update Posted: | 06/16/2020 |
| Actual Study Start Date: | 06/27/2019 |
| Estimated Primary Completion Date: | 05/31/2021 |
| Estimated Study Completion Date: | 11/30/2021 |
Condition or disease
Intervention/treatment
Device: Patients with known or suspected hydrocephalus
Phase
Arm Groups
| Arm | Intervention/treatment |
|---|---|
| Experimental: Patients with known or suspected hydrocephalus | Device: Patients with known or suspected hydrocephalus Participants receive a Hyperfine low field strength brain MRI scan in addition to a regularly scheduled standard clinical CT or MRI scan. |
Eligibility Criteria
| Ages Eligible for Study | 18 Years To 18 Years |
| Sexes Eligible for Study | All |
| Accepts Healthy Volunteers | Yes |
| Criteria | Inclusion Criteria: - Age 18 years or older - Suspected or confirmed diagnosis of hydrocephalus 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 |
Outcome
Primary Outcome Measures
1. Presence of hydrocephalus [Through study completion, an average of 60 min]
2. Quantitative ventricular volumes [Through study completion, an average of 60 min]
