Individual Cerebral Hemodynamic Oxygenation Relationships... | NCT06195345

Studies
Individual Cerebral Hemodynamic Oxygenation Relationships (ICHOR 1)

NCT06195345

Sponsor

Children's Hospital Los Angeles

Status

Recruiting

Last Update Posted

Apr 29, 2026Actual

Enrollment

1,000Estimated

Phase

Not provided

Conditions

HIE
TBI (Traumatic Brain Injury)
TBI
Hemodynamic Instability
Hypoxic-Ischemic Encephalopathy

Interventions

MR Imaging

Countries

United States

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

ID	Type	Description	Link
5K25HL153954-03	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Apr 2026

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

Nov 1, 2018Actual

Primary Completion Date

Nov 1, 2030Estimated

Completion Date

Nov 1, 2035Estimated

First Submitted Date

Dec 22, 2023

First Submission Date that Met QC Criteria

Dec 22, 2023

First Posted Date

Jan 8, 2024Actual

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

Apr 24, 2026

Last Update Posted Date

Apr 29, 2026Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Matthew Borzage, Principal Investigator, Children's Hospital Los AngelesPrincipal Investigator

Lead Sponsor

Children's Hospital Los AngelesOTHER

Collaborators

Name	Class
National Heart, Lung, and Blood Institute (NHLBI)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This is an observational study in patients who require clinical anesthesia. The main purpose of this study is to understand whether there are differences in the cerebral blood flow, and oxygen metabolism affected by different types of anesthesia. Subjects who require clinical anesthesia for a clinical MRI and for whom the use of anesthetics for the exam are in clinical equipoise are asked to join the study. All eligible subjects will be asked to provide informed consent before participating in the study.

Detailed Description

Treatment:

Those who meet eligibility criteria, and who undergo the informed consent, will have their MRI extended by up to 7.5 minutes for up to 5 times. Standard-of-care anesthesia safety, dose and monitoring will not be changed. During their MRI, the additional images acquired will teach us about cerebral blood flow and cerebral venous oxygenation. Participants will also have non-invasive monitoring of their hematocrit immediately following the exam.

Safety Assessment:

The experiment will occur in the standard-of-care clinical MRI environment. All patient safety and monitoring will remain in place. Throughout the induction, maintenance and recovery from anesthesia, all procedures will occur in the standard of care environment and will be overseen by trained clinical personnel.

Efficacy Assessment:

Structural, and/or cerebral blood flow and/or metabolism MRIs will be collected from all subjects.

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

1,000Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Pediatric Patients		Children scheduled for clinical MR imaging.	Diagnostic Test: MR Imaging

Interventions

Name	Type	Description	Arm Group Labels	Other Names
MR Imaging	Diagnostic Test	MR imaging pertaining to the patient and project (ICHOR 1)	Pediatric Patients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in cerebral blood flow (ml blood/100g/min)	Phase contrast (PC) acquisition via MRI will be used to assess any impact of anesthesia on cerebral blood flow.	Time points over which the change is assessed: change from (1) start of MRI, through (2) MRI completion, an average of 60 minutes.
Change in cerebral metabolic rate of oxygen (ml O2/100g/min)	T2 relaxation under spin tagging (TRUST) acquisition via MRI will be used to assess any impact of anesthesia on cerebral metabolic rate of oxygen.	Time points over which the change is assessed: change from (1) start of MRI, through (2) MRI completion, an average of 60 minutes.

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Individuals who are able to tolerate an MRI.
Are patients scheduled for a clinically indicated MRI.
Between birth and up to 18 years.

Exclusion Criteria:

Presence of an MRI-incompatible device or implant (e.g. pacemakers, stents)
Unable to tolerate the enclosed spaces and loud noises for the duration of time in scanner required to obtain an MRI.
Preterm infants less than 25 weeks
Any patient who is clinically too unstable to extend their MRI by up-to 7.5 minutes.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Minute

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Neonates and young children

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Hannah E Wiseman, MPH	Contact	323-361-3963		hwiseman@chla.usc.edu
Matthew T Borzage, PhD	Contact	323-601-5757		mborzage@chla.usc.edu

Overall Officials

Name	Affiliation	Role
Matthew Borzage, PhD	Children's Hospital Los Angeles	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Children's Hospital Los Angeles	Recruiting	Los Angeles	California	90027	United States

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000070642	Brain Injuries, Traumatic
D020925	Hypoxia-Ischemia, Brain

Ancestor Terms

ID	Term
D001930	Brain Injuries
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D008279	Magnetic Resonance Imaging
D003952	Diagnostic Imaging

Ancestor Terms

ID	Term
D014054	Tomography
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis

Browse Leaves

Not provided

Browse Branches

Not provided