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

NCT05904704 | Withdrawn

• 2 other identifiers: STUDY00025277NCI-2023-01433
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Intracranial Neoplasm

Outcome Measures

Primary Outcomes (2)

• 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.

  One hour of diagnostic imaging

• Quantification of hypoxic tumor volume

  Evaluated to determine the feasibility of obtaining oxygen MRI hypoxia maps.

  One hour of diagnostic imaging

Secondary Outcomes (2)

• Correlation between T1 and T2* sequence hypoxia volume

  One hour of diagnostic imaging

• Progression free survival

  Clinical follow up for up to 5 years

Study Arms (1)

Diagnostic (oxygen-enhanced MRI)

EXPERIMENTAL

Patients receive supplemental oxygen while undergoing standard of care MRI.

Procedure: Magnetic Resonance Imaging; Procedure: Oxygen Therapy

Interventions

Magnetic Resonance Imaging PROCEDURE

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

Diagnostic (oxygen-enhanced MRI)

Oxygen Therapy PROCEDURE

Receive supplemental oxygen

Also known as: supplemental oxygen therapy

Diagnostic (oxygen-enhanced MRI)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients (18 years of age or older) with a known or suspected intracranial tumor
• Able to provide informed written consent and/or acceptable surrogate capable of providing consent on the patient's behalf
• Legally authorized representative (LAR)-signed informed consent and assent obtained for those subjects identified as decisionally impaired
• Intracranial lesion known or suspected to be neoplastic greater than 10 mL as assessed by T2/fluid attenuated inversion recovery (FLAIR) magnetic resonance (MR) imaging
• Karnofsky performance score \> 60 or Eastern Cooperative Oncology Group (ECOG) \< 3 as assessed by referring clinician
• Planning to undergo or previously received therapeutic intervention for the intracranial tumor

You may not qualify if:

• Pregnant or breastfeeding
• Contraindication to supplemental oxygen administration, MRI, or intravenous gadolinium based contrast agents.
• Claustrophobia
• Weight greater than modality maximum capacity
• Presence of metallic foreign body or implanted medical devices in body not documented as MRI safe according to the Oregon Health \& Science University (OHSU) Department of Radiology guidelines (including but not limited to cardiac pacemaker, aneurysm clips, surgical clips, prostheses, artificial hearts, valves with steel parts, metal fragments, shrapnel, tattoos near the eye, or steel implants)
• Sickle cell disease
• Unsure of pregnancy status as assessed by Department of Radiology and Advanced Imaging Research Center (AIRC) guidelines
• Subjects for whom supplemental oxygen could be harmful such as people with potential for hypoventilation or chronic respiratory insufficiency (end-stage chronic obstructive pulmonary disease \[COPD\], obstructive sleep apnea \[OSA\] on continuous positive airway pressure \[CPAP\]/biphasic positive airway pressure \[Bi-PAP\], etc)
• Subjects with a relative contraindication to supplemental oxygen administration will not be provided oxygen but may still participate in the study
• Presence of any other co-existing condition that, in the judgment of the principal investigator, might increase the risk to the subject (i.e., plans for hospice or end of 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/social situations which might impact the endpoint of the study or limit compliance with study requirements

Sponsors & Collaborators

• OHSU Knight Cancer Institute: lead
• Oregon Health and Science University: collaborator

Study Sites (1)

OHSU Knight Cancer Institute

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Brain Neoplasms

Interventions

Magnetic Resonance Spectroscopy; Oxygen

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques; Chalcogens; Elements; Inorganic Chemicals; Gases

Study Officials

• Ramon Barajas

  OHSU Knight Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 6, 2023
• First Posted: June 15, 2023
• Study Start: April 12, 2023
• Primary Completion (Estimated): March 31, 2029
• Study Completion (Estimated): March 31, 2029
• Last Updated: November 14, 2025

Record last verified: 2025-11

Locations

US (1)