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Procedure
Oxygen-Enhanced MRI for Brain Tumors
N/A
Recruiting
Led By Ramon Barajas
Research Sponsored by OHSU Knight Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up clinical follow up for up to 5 years
Awards & highlights
No Placebo-Only Group
Summary
This trial looks at using MRI to create maps of oxygen levels in brain tumors to help design better treatments.
Who is the study for?
This trial is for adults over 18 with a suspected or known brain tumor larger than 10 mL. Participants must be able to consent, have a performance score indicating they can carry out daily activities, and may already be receiving treatment for the tumor. It's not suitable for those with sickle cell disease, poor vein access, pregnancy, certain metal implants, severe other illnesses or conditions that make MRI or oxygen therapy risky.
What is being tested?
The study tests if oxygen-enhanced MRI can create detailed maps of low-oxygen areas in brain tumors. This non-invasive technique could help understand how much of the tumor lacks oxygen which affects treatment effectiveness like radiation and chemotherapy.
What are the potential side effects?
There are generally no significant side effects associated with standard MRI procedures; however, some individuals might experience discomfort due to lying still in a confined space (claustrophobia) or from loud noises during the scan.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ clinical follow up for up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~clinical follow up for up to 5 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Generation of whole brain oxygen magnetic resonance imaging (MRI) data set
Quantification of hypoxic tumor volume
Secondary study objectives
Correlation between T1 and T2* sequence hypoxia volume
Progression free survival
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Diagnostic (oxygen-enhanced MRI)Experimental Treatment2 Interventions
Patients receive supplemental oxygen while undergoing standard of care MRI.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Magnetic Resonance Imaging
2017
Completed Phase 3
~1180
Oxygen Therapy
2019
N/A
~120
Find a Location
Who is running the clinical trial?
Oregon Health and Science UniversityOTHER
1,008 Previous Clinical Trials
7,414,289 Total Patients Enrolled
OHSU Knight Cancer InstituteLead Sponsor
236 Previous Clinical Trials
2,089,552 Total Patients Enrolled
Ramon BarajasPrincipal InvestigatorOHSU Knight Cancer Institute
1 Previous Clinical Trials
50 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I should avoid extra oxygen due to my severe lung or breathing condition.I do not have any serious illnesses that could affect my participation in the study.I cannot have MRI scans or certain IV contrast agents due to health reasons.I have sickle cell disease.I have a history of difficult IV access.I am planning or have had treatment for a brain tumor.I am an adult with a brain tumor.My legal representative has signed the consent for me as I'm unable to make decisions.I have a brain lesion larger than 10 mL suspected to be cancer.I can care for myself but may not be able to do active work.
Research Study Groups:
This trial has the following groups:- Group 1: Diagnostic (oxygen-enhanced MRI)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.