Using oxygen-enhanced MRI to create hypoxia maps in brain tumor patients
Feasibility of Oxygen Enhanced MRI in Assessment of Malignant Brain Tumors
NA · OHSU Knight Cancer Institute · NCT05904704
This study is testing if using extra oxygen during MRI scans can help create better maps of low oxygen areas in brain tumors to improve treatment options for patients.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | OHSU Knight Cancer Institute (other) |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Portland, Oregon) |
| Trial ID | NCT05904704 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the feasibility of using oxygen-enhanced magnetic resonance imaging (MRI) to generate hypoxia maps in patients with intracranial tumors. Hypoxia, or low oxygen levels, is common in malignant brain tumors and can hinder the effectiveness of treatments like radiation and chemotherapy. By administering supplemental oxygen during standard MRI procedures, the study aims to improve the imaging signal and provide a better understanding of tumor hypoxia. This information could lead to more effective, personalized therapies for patients with brain tumors.
Who should consider this trial
Good fit: Ideal candidates include adult patients aged 18 or older with known or suspected intracranial tumors who can provide informed consent.
Not a fit: Patients who are pregnant, breastfeeding, or have contraindications to MRI or oxygen therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enable more targeted and effective treatments for patients with malignant brain tumors.
How similar studies have performed: While the use of oxygen-enhanced MRI is a novel approach, similar imaging techniques have shown promise in other studies.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Portland, Oregon
- OHSU Knight Cancer Institute — Portland, Oregon, United States (RECRUITING)
Study contacts
- Principal investigator: Ramon Barajas — OHSU Knight Cancer Institute
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Intracranial Neoplasm