Hydrocephalus Clinical Trial
Official title:
Evaluation of Hyperfine Low Field Strength Portable Point-of-Care Magnetic Resonance Imaging System in Hydrocephalus and Other Conditions Prompting Outpatient Brain Imaging
NCT number | NCT04436068 |
Other study ID # | 832913 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | June 28, 2019 |
Est. completion date | January 2027 |
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.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | January 2027 |
Est. primary completion date | January 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Pennsylvania | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
University of Pennsylvania |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Presence of hydrocephalus | Presence or absence of hydrocephalus will be determined qualitatively based on neuroradiologist interpretation of low-field MRI scans and companion standard clinical MRI or CT scans to evaluate performance using the low-field device to make this determination. | Through study completion, an average of 60 minutes | |
Primary | Quantitative ventricular volumes | Quantitative ventricular volumes (mL) will be obtained and compared for low-field and companion standard clinical MRI scans. | Through study completion, an average of 60 minutes | |
Primary | Presence of other important imaging findings | Presence of other important imaging findings will be determined qualitatively based on neuroradiologist interpretation of low-field MRI scans and companion standard clinical MRI or CT scans. | Through study completion, an average of 60 minutes |
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