Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

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

Study information

Verified date July 2023
Source University of Pennsylvania
Contact Marisa Sanchez
Phone 215-901-9994
Email Marisa.Sanchez@pennmedicine.upenn.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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. 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.


Recruitment information / eligibility

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

Study Design


Intervention

Device:
Hyperfine MRI scan
Participants receive a Hyperfine low field strength brain MRI scan in addition to a regularly scheduled standard clinical CT or MRI scan.

Locations

Country Name City State
United States University of Pennsylvania Philadelphia Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

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
See also
  Status Clinical Trial Phase
Recruiting NCT06040697 - Formative Usability Assessment of Wireless Thermal Anisotropy Devices
Terminated NCT02408757 - Sonographic Monitoring of Weaning of Cerebrospinal Fluid Drainages
Terminated NCT01863381 - Comparison of Continuous Non-Invasive and Invasive Intracranial Pressure Measurement N/A
Completed NCT00652470 - A Study Comparing Two Treatments for Infants With Hydrocephalus Phase 2
Completed NCT00196196 - A Precision and Accuracy Study of the Codman Valve Position Verification (VPV) System. Phase 3
Terminated NCT05501002 - Pilot Study to Evaluate the CereVasc® eShunt® System in the Treatment of Communicating Hydrocephalus N/A
Active, not recruiting NCT05068128 - Combined Flow and Pressure Study of Craniospinal Dynamic
Completed NCT04496414 - Bactiseal Catheter Safety Registry in China
Terminated NCT02900222 - Study of Choroid Plexus Cauterization in Patients With Hydrocephalus N/A
Recruiting NCT04099823 - MR Evaluation of Cerebrospinal Fluid (CSF) Dynamics N/A
Unknown status NCT02775136 - An Evaluation of a Non-invasive Brain Monitor N/A
Completed NCT00692744 - Quality of Life in Elderly After Aneurysmal Subarachnoid Hemorrhage (SAH) N/A
Recruiting NCT04758611 - The ETCHES I Study (Endovascular Treatment of Communicating Hydrocephalus With an Endovascular Shunt) N/A
Completed NCT03595033 - Hydrocephalus iPad-App Based Intervention Study N/A
Completed NCT04207229 - CERTAS Programmable Valve Registry
Completed NCT01976559 - Comparison of Continuous Noninvasive and Invasive Intracranial Pressure Measurement--Celda Infusion Subprotocol N/A
Terminated NCT01973764 - Intraventricular Drain Insertion: Comparison of Ultrasound-guided and Landmark-based Puncture of the Ventricular System N/A
Completed NCT02381977 - Prevalence of Acute Critical Neurological Disease in Children: a Global Epidemiological Assessment N/A
Recruiting NCT06086561 - Longitudinal Measurements of Flow in Cerebrospinal Fluid Shunts With a Wireless Thermal Anisotropy Measurement Device N/A
Recruiting NCT05910944 - European Study of Prodromal iNPH