Clinical trial NCT05904704: Oxygen-Enhanced MRI for Generating Hypoxia Maps in Patients With Intracranial Tumors
Official title: Feasibility of Oxygen Enhanced MRI in Assessment of Malignant Brain Tumors
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Intracranial Neoplasm
Lead sponsor: OHSU Knight Cancer Institute
Sponsor class: OTHER
Collaborators: name: Oregon Health and Science University
First posted: 2023-06-15
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Generation of whole brain oxygen magnetic resonance imaging (MRI) data set
timeFrame: One hour of diagnostic imaging
measure: Quantification of hypoxic tumor volume
timeFrame: One hour of diagnostic imaging
Secondary outcomes:
measure: Correlation between T1 and T2* sequence hypoxia volume
timeFrame: One hour of diagnostic imaging
measure: Progression free survival
timeFrame: Clinical follow up for up to 5 years
Other outcomes:
Locations:
city: Portland
country: United States
facility: OHSU Knight Cancer Institute
state: Oregon
Study officials:
affiliation: OHSU Knight Cancer Institute
name: Ramon Barajas
role: PRINCIPAL_INVESTIGATOR
References: