Longitudinal Investigation of Brain Blood Flow Changes in... | NCT04668261

Studies
Longitudinal Investigation of Brain Blood Flow Changes in Neurosurgical Patients

NCT04668261

Sponsor

University of Zurich

Status

Recruiting

Last Update Posted

Dec 29, 2020Actual

Enrollment

400Estimated

Phase

Not provided

Conditions

Brain Blood Flow Impairment

Interventions

Advanced imaging investigation

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2020

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2021Estimated

Primary Completion Date

Nov 1, 2025Estimated

Completion Date

Nov 1, 2027Estimated

First Submitted Date

Dec 8, 2020

First Submission Date that Met QC Criteria

Dec 8, 2020

First Posted Date

Dec 16, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 28, 2020

Last Update Posted Date

Dec 29, 2020Actual

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

400Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Neurosurgical patients		• Neurosurgical diseases with the potential to alter blood flow to the brain: Cerebrovascular disease Brain tumors Normal Pressure Hydrocephalus	Other: Advanced imaging investigation
Healthy subjects		Male and Female subjects >18 years of age Written Informed Consent by the participant after information about the project. Foreign speaking healthy subjects should be accompanied by a person with sufficient German language proficiency to act as a translator	Other: Advanced imaging investigation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Advanced imaging investigation	Other	MRI imaging	Healthy subjects Neurosurgical patients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
• Longitudinal observation of brain blood flow changes in neurosurgical patients with or without a neurosurgical intervention as compared to a healthy cohort.	blood flow changes will be assessed with quantitative blood oxygenation-level dependent cerebrovascular reactivity measurements	5 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion criteria

Patients:

Male and Female subjects >18 years of age
Written informed consent after participants' information. Foreign speaking patients should be accompanied by a person with sufficient German language proficiency to act as a translator
Neurosurgical diseases with the potential to alter blood flow to the brain:
- Cerebrovascular disease
- Brain tumors
- Normal Pressure Hydrocephalus

Healthy subjects:

Male and Female subjects >18 years of age
Written Informed Consent by the participant after information about the project. Foreign speaking healthy subjects should be accompanied by a person with sufficient German language proficiency to act as a translator

Exclusion criteria:

Patients:

Unwilling or unable to co-operate with breathing maneuvers
Respiratory or cardiac limitations to breathing through a mask
Medical contra-indications to limited hypercapnia (high CO2 - 50 mmHg) or hypocapnia (low CO2 - 30 mmHg) (i.e., known increased intracerebral pressure, metabolic acidosis or alkalosis)
Standard contraindications for MRI scanning
Verbal confirmed pregnancy
Known multiple intracranial diseases
Presence of intracranial hemorrhage within the last 3 months
Symptomatic increased intracranial pressure

Healthy subjects:

Unwilling or unable to co-operate with breathing maneuvers
Respiratory or cardiac limitations to breathing through a mask
Medical contra-indications to limited hypercapnia (high CO2 - 50 mmHg) or hypocapnia (low CO2 - 30 mmHg) (i.e., known increased intracerebral pressure, metabolic acidosis or alkalosis)
Standard contraindications for MRI scanning
Verbal confirmed pregnancy
Anamnesticly a history of neurological disease or current neurological deficits.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Neurosurgical patients with the potential to have altered blood flow to the brain

Sampling Method

Non-Probability Sample

Name	Role	Phone	Extension	Email
Jorn Fierstra, MD, PhD	Contact	0041 442553169		jorn.fierstra@usz.ch
Luca Regli, Professor	Contact	0041442552992		Luca.regli@usz.ch