Quantifying Oxygen Utilization of Tumors Using Oxygen-Enhanced Molecular MRI

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-07

Study Completion Date

2021-09-16

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.

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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.

Conditions

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Malignant Brain Neoplasm

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

oxygen-enhanced molecular MRI in healthy volunteers.

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Feasibility (ASL,pH-Weighted amine CEST, O2-Weighted SAGE-EPI)

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.

Group Type EXPERIMENTAL

Arterial Spin Labeling Magnetic Resonance Imaging

Intervention Type PROCEDURE

Undergo ASL scan

pH-Weighted amine CEST

Intervention Type PROCEDURE

Undergo pH Weighted amine CEST

Oxygen-weighted SAGE-EPI

Intervention Type PROCEDURE

Undergo Oxygen-weighted SAGE-EPI

Interventions

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Arterial Spin Labeling Magnetic Resonance Imaging

Undergo ASL scan

Intervention Type PROCEDURE

pH-Weighted amine CEST

Undergo pH Weighted amine CEST

Intervention Type PROCEDURE

Oxygen-weighted SAGE-EPI

Undergo Oxygen-weighted SAGE-EPI

Intervention Type PROCEDURE

Other Intervention Names

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ARTERIAL SPIN LABELING FUNCTIONAL MRI Arterial Spin Labeling MRI ASL ASL fMRI Amine CEST CEST-EPI SAGE-EPI Hypoxia MRI

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

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes