RECRUITING

Individual Cerebral Hemodynamic Oxygenation Relationships

Conditions

Anesthesia Anesthesia; Reaction Magnetic Resonance Imaging Cerebral Blood Flow Cerebral Metabolism

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This is a randomized controlled trial 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 two types of anesthesia: propofol or sevoflurane. Subjects who require clinical anesthesia for a clinical MRI and for whom the use of propofol and sevoflurane are in clinical equipoise will be offered to have the anesthesia they will receive during their MRI randomized. All eligible subjects will be asked to provide informed consent before participating in the study.

Official Title

Cerebral Hemodynamics- ICHOR II

Quick Facts

Study Start:2020-06-09

Study Completion:2026-09-10

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04435834

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:Not specified to 1 Year

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD

Inclusion Criteria	Exclusion Criteria
* Patients who are scheduled for a clinically indicated MRI at the sponsor institution. * Patients who are able to tolerate an MRI. * Patients who require clinical anesthesia for their MRI. * Patients with conditions not believed to alter oxygen metabolism or blood flow in the brain, including but not limited to patients with orthopedic indications, undescended testicles, hernia repairs, term equivalent age scans. * Patients who have no medical conditions that make the use of propofol or sevoflurane better for their clinical outcome. * Patients between birth and up-to 1 year of age. * Patients with conditions known to alter oxygen metabolism or blood flow in the brain, e.g. traumatic brain injury, hypoxic ischemic encephalopathy, tumor.	* Patients with an MRI-incompatible device or implant (e.g. pacemakers, stents) * Preterm infants less than 25 weeks postmenstrual age (PMA) at the time of the scan. * Patients who are clinically too unstable to extend their MRI by up-to 10 minutes. * Patients who do not require clinical anesthesia. * Patients at risk for propofol infusion syndrome (known severe metabolic acidosis, hyperkalemia, lipemia, rhabdomyolysis, hepatomegaly, renal failure, ECG ST segment elevation, and/or cardiac failure) * Patients at risk for sevoflurane-based malignant hyperthermia (known ryanodine receptor mutations) * Patient at risk for sensitivity to volatile halogenated anesthetic agents (known congenital Long QT Syndrome or patients taking drugs that can prolong the QT interval), * Patients with Perioperative Hyperkalemia (known neuromuscular disease, particularly Duchenne muscular dystrophy)

Inclusion Criteria

Exclusion Criteria

* Patients who are scheduled for a clinically indicated MRI at the sponsor institution.
* Patients who are able to tolerate an MRI.
* Patients who require clinical anesthesia for their MRI.
* Patients with conditions not believed to alter oxygen metabolism or blood flow in the brain, including but not limited to patients with orthopedic indications, undescended testicles, hernia repairs, term equivalent age scans.
* Patients who have no medical conditions that make the use of propofol or sevoflurane better for their clinical outcome.
* Patients between birth and up-to 1 year of age.
* Patients with conditions known to alter oxygen metabolism or blood flow in the brain, e.g. traumatic brain injury, hypoxic ischemic encephalopathy, tumor.

* Patients with an MRI-incompatible device or implant (e.g. pacemakers, stents)
* Preterm infants less than 25 weeks postmenstrual age (PMA) at the time of the scan.
* Patients who are clinically too unstable to extend their MRI by up-to 10 minutes.
* Patients who do not require clinical anesthesia.
* Patients at risk for propofol infusion syndrome (known severe metabolic acidosis, hyperkalemia, lipemia, rhabdomyolysis, hepatomegaly, renal failure, ECG ST segment elevation, and/or cardiac failure)
* Patients at risk for sevoflurane-based malignant hyperthermia (known ryanodine receptor mutations)
* Patient at risk for sensitivity to volatile halogenated anesthetic agents (known congenital Long QT Syndrome or patients taking drugs that can prolong the QT interval),
* Patients with Perioperative Hyperkalemia (known neuromuscular disease, particularly Duchenne muscular dystrophy)

Contacts and Locations

Study Contact

Hannah Wiseman

CONTACT

323-361-3963

hwiseman@chla.usc.edu

Principal Investigator

Matthew Borzage, PhD

PRINCIPAL_INVESTIGATOR

Children's Hospital Los Angeles

Study Locations (Sites)

Children's Hospital Los Angeles

Los Angeles, California, 90027

United States

Collaborators and Investigators

Sponsor: Matthew Borzage

Matthew Borzage, PhD, PRINCIPAL_INVESTIGATOR, Children's Hospital Los Angeles

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-06-09

Study Completion Date2026-09-10

Study Record Updates

Study Start Date2020-06-09

Study Completion Date2026-09-10

Terms related to this study

Keywords Provided by Researchers

Magnetic Resonance Imaging
Cerebral Blood Flow
Cerebral Metabolism
Anesthesia

Additional Relevant MeSH Terms

Anesthesia
Anesthesia; Reaction