Quantifying Oxygen Utilization of Tumors Using Oxygen-Enhanced Molecular MRI

Jonsson Comprehensive Cancer Center

Status: Terminated

Conditions: Malignant Brain Neoplasm

Treatments: Procedure: Arterial Spin Labeling Magnetic Resonance Imaging; Procedure: Oxygen-weighted SAGE-EPI; Procedure: pH-Weighted amine CEST

Study type: Interventional

Funder types: Other

Identifiers

NCT04460495

NCI-2020-03446 (Registry Identifier)

20-000449

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 8 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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8 participants in 1 patient group

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

Experimental group

Description:

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.

Treatment:

Procedure: pH-Weighted amine CEST

Procedure: Oxygen-weighted SAGE-EPI

Procedure: Arterial Spin Labeling Magnetic Resonance Imaging