Quantifying Oxygen Utilization of Tumors Using Oxygen-Enhanced Molecular MRI

Study Overview
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Brief Summary
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This trial looks to study the safety and feasibility of using oxygen-enhanced molecular MRI to understand how cancer cells use oxygen differently than normal cells. Cancer cells tend to utilize (or not utilize) oxygen differently than normal cells. By using the oxygen-enhanced molecular MRI, researchers will be able to create spatial maps depicting areas of abnormal oxygen utilization unique to cancer. This type of information may be useful for diagnosing new cancers, understanding various subtypes of cancer that might utilize oxygen differently, or this information may be useful for evaluating new drugs that impact cancer metabolism.

Detailed Description
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PRIMARY OBJECTIVES: I. Determine the safety, feasibility, and sensitivity of oxygen-enhanced molecular magnetic resonance imaging (MRI) in healthy volunteers. II. Measure oxygen-enhanced molecular MRI characteristics in human brain tumors. OUTLINE: Participants undergo arterial spin labeling (ASL) MRI scan and amine chemical exchange saturation transfer spin-and-gradient echo echo-planar imaging using amine proton CEST echo spin-and-gradient echo (SAGE) EPI (CEST-SAGE-EPI) while breathing normal room air (21% oxygen). Patients then undergo another ASL MRI and CEST-SAGE-EPI while breathing medical grade air (100% oxygen). Total ASL MRI and CEST-SAGE-EPI imaging scan time is 60 minutes.

Official Title
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Quantifying Tumor Respiration Using Oxygen-Enhanced Molecular MRI

Conditions
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Malignant Brain Neoplasm

Intervention / Treatment
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* Procedure: Arterial Spin Labeling Magnetic Resonance Imaging
* Procedure: pH-Weighted amine CEST
* Procedure: Oxygen-weighted SAGE-EPI


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy volunteers will include persons who at the time of scans do not present with known neurological conditions that might impact tissue imaging results Patient participants should have suspected or pathology-confirmed diagnosis of a brain tumor (any histological subtype including brain metastases) All participants must be able to obtain an MRI scan and must be able to safely breathe high concentrations of oxygen Exclusion Criteria: Participants with contraindications to MRI including metal implants Participants who are deemed not able to or not safe to breath high concentrations of oxygen
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Interventional Model Description: oxygen-enhanced molecular MRI in healthy volunteers.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Feasibility (ASL,pH-Weighted amine CEST, O2-Weighted SAGE-EPI)<br>Participants undergo ASL perfusion, pH-weighted amine CEST, and oxygen-weighted SAGE-EPI , while breathing normal room air (21% oxygen). Patients then undergo another ASL perfusion, pH-weighted amine CEST, and oxygen-weighted SAGE-EPI while breathing medical grade air (100% oxygen). Total ASL perfusion, pH-weighted amine CEST, and oxygen-weighted SAGE-EPI imaging scan time is 60 minutes. | Procedure: Arterial Spin Labeling Magnetic Resonance Imaging<br>* Undergo ASL scan<br>* Other names: ASL fMRI;Procedure: pH-Weighted amine CEST<br>* Undergo pH Weighted amine CEST<br>* Other names: CEST-EPI;Procedure: Oxygen-weighted SAGE-EPI<br>* Undergo Oxygen-weighted SAGE-EPI<br>* Other names: Hypoxia MRI;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in pH-weighted amine CEST MRI to measure tumor acidity (MTRasym at 3ppm) before/after oxygen enrichment | Will be measured by voxel-wise t-tests via analysis of functional NeuroImages (AFNI) software between the average R2' and MTRasym during normal room air and medical grade air. | Baseline and two hours after Oxygen enrichment | 
| Change in oxygen-weighted SAGE-EPI to measure oxygen extraction (R2') before and after oxygen enrichment | We will perform voxel-wise t-tests via AFNI software between the average R2' and MTRasym during normal room air and medical grade air. | Baseline and two hours after Oxygen enrichment | 
| Tumor blood flow as measured by cerebral blood flow (CBF) from arterial spin labeling (ASL). | Change in ASL perfusion estimates of relative cerebral blood flow (CBF) before and after oxygen enrichment | Baseline and two hours after Oxygen enrichment |