Ignite Creation Date:
2025-12-24 @ 1:03 PM
Ignite Modification Date:
2026-01-15 @ 1:17 PM
Study NCT ID:
NCT04668261
Status:
RECRUITING
Last Update Posted:
2020-12-29
First Post:
2020-12-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Longitudinal Investigation of Brain Blood Flow Changes in Neurosurgical Patients
Sponsor:
University of Zurich
Organization:
Study Overview
Official Title:
Longitudinal Investigation of Brain Blood Flow Changes in Neurosurgical Patients
Status:
RECRUITING
Status Verified Date:
2020-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Primary study objective:
• Longitudinal observation of brain blood flow changes in neurosurgical patients with or without a neurosurgical intervention as compared to a healthy cohort.
Secondary study objectives:
* Longitudinal observation of hemodynamic patterns versus structural brain tissue changes in neurosurgical patients.
* Changes in blood flow patterns and structural brain tissue after neurosurgical interventions as compared to a healthy cohort.
* Determining hemodynamic imaging patterns that can be tested as novel imaging markers.
• Longitudinal observation of brain blood flow changes in neurosurgical patients with or without a neurosurgical intervention as compared to a healthy cohort.
Secondary study objectives:
* Longitudinal observation of hemodynamic patterns versus structural brain tissue changes in neurosurgical patients.
* Changes in blood flow patterns and structural brain tissue after neurosurgical interventions as compared to a healthy cohort.
* Determining hemodynamic imaging patterns that can be tested as novel imaging markers.
Detailed Description:
Primary study objective:
• to study the longitudinal observation of brain blood flow changes in neurosurgical patients to evaluate the effect of surgical or conservative treatment on the brain structural and hemodynamic integrity.
Secondary study objectives:
* To observe the relationship between longitudinal changes in hemodynamic patterns and structural brain tissue changes in neurosurgical patients.
* To determine different hemodynamic patterns that may be used as novel imaging biomarkers in future studies.
4.2 Outcomes
Outcomes of the project:
Primary endpoint:
To find correlation between course of disease, neurosurgical intervention and changes in brain blood flow and brain structure.
Secondary endpoints:
* Correlation between progression of disease and hemodynamic patterns over time (ie. novel imaging markers)
* Correlation of clinical management (neurosurgical treatment vs. best medical care) and changes in brain blood flow.
• to study the longitudinal observation of brain blood flow changes in neurosurgical patients to evaluate the effect of surgical or conservative treatment on the brain structural and hemodynamic integrity.
Secondary study objectives:
* To observe the relationship between longitudinal changes in hemodynamic patterns and structural brain tissue changes in neurosurgical patients.
* To determine different hemodynamic patterns that may be used as novel imaging biomarkers in future studies.
4.2 Outcomes
Outcomes of the project:
Primary endpoint:
To find correlation between course of disease, neurosurgical intervention and changes in brain blood flow and brain structure.
Secondary endpoints:
* Correlation between progression of disease and hemodynamic patterns over time (ie. novel imaging markers)
* Correlation of clinical management (neurosurgical treatment vs. best medical care) and changes in brain blood flow.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: