Oxygen-Enhanced MRI for Generating Hypoxia Maps in Patients With Intracranial Tumors

Last updated: June 5, 2025
Sponsor: OHSU Knight Cancer Institute
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Gliomas

Brain Tumor

Treatment

Oxygen Therapy

Magnetic Resonance Imaging

Clinical Study ID

NCT05904704
STUDY00025277
STUDY00025277
NCI-2023-01433
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Adult patients (18 years of age or older) with a known or suspected intracranialtumor

  • Able to provide informed written consent and/or acceptable surrogate capable ofproviding consent on the patient's behalf

  • Legally authorized representative (LAR)-signed informed consent and assent obtainedfor those subjects identified as decisionally impaired

  • Intracranial lesion known or suspected to be neoplastic greater than 10 mL asassessed by T2/fluid attenuated inversion recovery (FLAIR) magnetic resonance (MR)imaging

  • Karnofsky performance score > 60 or Eastern Cooperative Oncology Group (ECOG) < 3 asassessed by referring clinician

  • Planning to undergo or previously received therapeutic intervention for theintracranial tumor

Exclusion

Exclusion Criteria:

  • Pregnant or breastfeeding

  • Contraindication to supplemental oxygen administration, MRI, or intravenousgadolinium based contrast agents.

  • Claustrophobia

  • Weight greater than modality maximum capacity

  • Presence of metallic foreign body or implanted medical devices in body notdocumented as MRI safe according to the Oregon Health & Science University (OHSU) Department of Radiology guidelines (including but not limited to cardiacpacemaker, aneurysm clips, surgical clips, prostheses, artificial hearts,valves with steel parts, metal fragments, shrapnel, tattoos near the eye, orsteel implants)

  • Sickle cell disease

  • Unsure of pregnancy status as assessed by Department of Radiology and AdvancedImaging Research Center (AIRC) guidelines

  • Subjects for whom supplemental oxygen could be harmful such as people withpotential for hypoventilation or chronic respiratory insufficiency (end-stagechronic obstructive pulmonary disease [COPD], obstructive sleep apnea [OSA] oncontinuous positive airway pressure [CPAP]/biphasic positive airway pressure [Bi-PAP], etc)

  • Subjects with a relative contraindication to supplemental oxygen administrationwill not be provided oxygen but may still participate in the study

  • Presence of any other co-existing condition that, in the judgment of the principalinvestigator, might increase the risk to the subject (i.e., plans for hospice or endof life care)

  • Poor peripheral intravenous access evaluated by patient history

  • Presence of other serious systemic illnesses, including: uncontrolled infection,other uncontrolled malignancy, uncontrolled diabetes type II, or psychiatric/socialsituations which might impact the endpoint of the study or limit compliance withstudy requirements

Study Design

Total Participants: 20
Treatment Group(s): 2
Primary Treatment: Oxygen Therapy
Phase:
Study Start date:
April 12, 2023
Estimated Completion Date:
March 31, 2029

Study Description

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.

Connect with a study center

  • OHSU Knight Cancer Institute

    Portland, Oregon 97239
    United States

    Site Not Available

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