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Intracranial NeoplasmNCT05904704

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

A study testing Magnetic Resonance Imaging and Oxygen Therapy in people with Intracranial Neoplasm, run by OHSU Knight Cancer Institute at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Intracranial Neoplasm
What is being tested?
Magnetic Resonance Imaging and Oxygen Therapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteUnited States
Study dates
12 Apr 2023to 31 Mar 2029
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 12Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • OHSU Knight Cancer Institute

    Portland, Oregon, 97239

Other trials in United States

About this study

Official title: Feasibility of Oxygen Enhanced MRI in Assessment of Malignant Brain Tumors

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.

Read the detailed description

PRIMARY OBJECTIVE:

  1. Determine the feasibility of generating hypoxia maps from oxygen MRI.

SECONDARY OBJECTIVES:

  1. 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.

Being tested
Magnetic Resonance Imaging, Oxygen Therapy
Medical subject headings
Brain Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Magnetic Resonance ImagingProcedure or surgery

    Also called Magnetic Resonance, Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance

    Undergo MRI

  • Oxygen TherapyProcedure or surgery

    Also called supplemental oxygen therapy

    Receive supplemental oxygen

Study groups in NCT05904704
Study groupRoleWhat they receive
Diagnostic (oxygen-enhanced MRI)ExperimentalPatients receive supplemental oxygen while undergoing standard of care MRI.
Receives: Procedure: Magnetic Resonance Imaging; Procedure: Oxygen Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: One hour of diagnostic imaging

  2. Quantification of hypoxic tumor volume

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

    Measured: One hour of diagnostic imaging

Secondary outcomes (2)

  1. 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.

    Measured: One hour of diagnostic imaging

  2. 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.

    Measured: Clinical follow up for up to 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jun 2023
  2. Study start12 Apr 2023
  3. Primary completion31 Mar 2029 (estimated)
  4. Study completion31 Mar 2029 (estimated)

Why it stopped: no enrollment

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05904704
Sponsor's protocol ID
STUDY00025277
Other IDs
NCI-2023-01433, STUDY00025277
Status last verified
Nov 2025
First submitted
6 Jun 2023
Last updated
14 Nov 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Magnetic Resonance Imaging and Oxygen Therapy in people with Intracranial Neoplasm, run by OHSU Knight Cancer Institute at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 14 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Generation of whole brain oxygen magnetic resonance imaging (MRI) data set (time frame: One hour of diagnostic imaging). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05904704.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2025.

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