An interventional study of Magnetic Resonance Imaging and Oxygen Therapy in Intracranial Neoplasm, sponsored by OHSU Knight Cancer Institute. Withdrawn at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-11-14.
Sponsored by OHSU Knight Cancer Institute · Not applicable, Interventional, and Diagnostic
This clinical trial evaluates the feasibility of performing oxygen-enhanced magnetic resonance imaging (MRI) to generate hypoxia maps in patients with intracranial tumors. Decreased levels of oxygen (hypoxia) is a hallmark of malignant brain tumors. Chronic hypoxia is a stimulator of blood vessel formation, which is required for tumor growth and spread. Hypoxia also limits the effectiveness of radiation and chemotherapy. MRI is an imaging technique that uses radiofrequency waves and a strong magnetic field rather than x-rays to provide detailed pictures of internal organs and tissues. The administration of inhaled oxygen allows for an increased MRI signal effect size. Oxygen-enhanced MRI may be a non-invasive method that can physiologically estimate tissue hypoxia. With a better understanding of the extent of tumor hypoxia, more effective and patient-specific therapies could be devised to halt malignant tumor growth.
PRIMARY OBJECTIVE:
I. Determine the feasibility of generating hypoxia maps from oxygen MRI.
SECONDARY OBJECTIVES:
I. Evaluate the association between oxygen MRI hypoxia maps generated using T2* and T1 MRI sequences.
II. Evaluate the association between oxygen MRI hypoxia maps and progression free survival.
OUTLINE:
Patients receive supplemental oxygen while undergoing standard of care MRI.
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Exclusion Criteria:
Contraindication to supplemental oxygen administration, MRI, or intravenous gadolinium based contrast agents.
Patients receive supplemental oxygen while undergoing standard of care MRI.
Procedure: Magnetic Resonance Imaging · Procedure: Oxygen Therapy
Undergo MRI
Also known as: Magnetic Resonance, Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR, MR Imaging, MRI, MRI Scan, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging
Receive supplemental oxygen
Also known as: supplemental oxygen therapy
Generation of whole brain oxygen magnetic resonance imaging (MRI) data set
Evaluated to determine the feasibility of obtaining oxygen MRI hypoxia maps. Following completion of cohort enrollment, the generation of each hypoxia map will be independently scored as a dichotomous variable; successful or non-successful. The successful generation of a hypoxia map from either a T1 or T2\* approach in 85% of the cohort of patients will need to be achieved for the imaging modality to be deemed feasible for the purposes of this study. Will provide the estimated proportion of success rate for each metric along with the corresponding 95% exact confidence interval.
Time frame: One hour of diagnostic imaging
Quantification of hypoxic tumor volume
Evaluated to determine the feasibility of obtaining oxygen MRI hypoxia maps.
Time frame: One hour of diagnostic imaging
Correlation between T1 and T2* sequence hypoxia volume
Will determine the association between oxygen MRI hypoxia maps generated using T2\* and T1 MRI sequences. Assessed using Pearson's correlation coefficient.
Time frame: One hour of diagnostic imaging
Progression free survival
Will perform Kaplan Meier analysis of progression free survival stratified by median T1 and T2\* hypoxic volume to determine the association between oxygen MRI hypoxia maps and progression free survival. A Cox regression model will also be explored by treating hypoxic volume as a continuous variable.
Time frame: Clinical follow up for up to 5 years
This study is withdrawn, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.
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OHSU Knight Cancer Institute