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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03212976
Other study ID # 20170130
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 26, 2017
Est. completion date December 2024

Study information

Verified date September 2023
Source University of Miami
Contact Ashish Shah, MD
Phone 305-243-6946
Email ashish.shah@jhsmiami.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study is designed to evaluate the accuracy of a non-invasive method phase-contrast magnetic resonance imaging (MR-ICP) for assessing intracranial pressure (Phase 1). To perform second phase contrast imaging to evaluate the patency and flow of ventricular catheters after MR-ICP imaging (Phase 2).


Description:

The study will be divided into 2 phases. In Phase 1, patients with an intracranial pressure monitor will be recruited to the study, while in Phase 2, patients with shunts or Cerebral Spinal Fluid (CSF) access devices (Ommaya, reservoir, etc.) will be eligible for the study. Two separate groups of patients will be recruited to each phase of the study. Each phase of the study will involve MR-ICPs. The MR-ICP is an extra 5-10 minute sequence at the end of a MRI that assesses the pressure in the head. The MRI will take scans of the brain during different phases of the cardiac cycle and will assess the volume changes while the patient is lying flat. The pressure in the head will be estimated based on these calculations. This estimate will be compared to the pressure in the head as determined by the ICP monitor.


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date December 2024
Est. primary completion date December 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 99 Years
Eligibility Inclusion Criteria: - Patients referred for a MRI by Attendings in the Department of Neurological Surgery at the University of Miam with intracranial pathology with external ventricular drains (EVDs) or intracranial bolts placed for hydrocephalus or intracranial hypertension. Bolts must be placed prior to enrollment in the study to avoid any alterations in standard procedure - All pathological entities that produce intracranial hypertension will be included (trauma, tumor, vascular, infectious, inflammatory, etc). - Patients must undergo a MRI for another clinically indicated reason (diagnosis, surveillance, cervical MRI clearance, prognosis, etc). - English and Spanish-speaking patients Exclusion Criteria: - Unable to obtain MRI due to prior implants, metallic material, inability to sit still - Refractory intracranial hypertension (not controlled with medications, surgery, or EVD) - Unable to obtain informed consent

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Phase contrast magnetic resonance imaging
Phase-contrast magnetic resonance imaging will be done to assess intracranial pressure

Locations

Country Name City State
United States Jackson Memorial Hospital Miami Florida
United States University of Miami Hospital Miami Florida

Sponsors (1)

Lead Sponsor Collaborator
University of Miami

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Intracranial Pressure Measurement Ratio of intracranial volume 1 day
Primary Patency of ventricular catheters Patency of ventricular catheters will be measured using multi-voxel MRI-ICP to qualitatively assess presence of CSF flow. 7 days
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