Quantifying Oxygen Utilization of Tumors Using Oxygen-Enhanced Molecular MRI

Not Applicable

Terminated

• Conditions: Malignant Brain Neoplasm
• Interventions: Procedure: Arterial Spin Labeling Magnetic Resonance Imaging; Procedure: pH-Weighted amine CEST; Procedure: Oxygen-weighted SAGE-EPI

• Registration Number: NCT04460495
• Lead Sponsor: Jonsson Comprehensive Cancer Center

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2020-06-15
• Study First Submitted QC: 2020-07-06
• Study Start: 2020-07-07
• Study First Posted: 2020-07-07
• Primary Completion: 2021-09-16
• Study Completion: 2021-09-16
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-04
• Last Update Posted: 2022-05-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 8

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Feasibility (ASL,pH-Weighted amine CEST, O2-Weighted SAGE-EPI)	Arterial Spin Labeling Magnetic Resonance Imaging	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.
Feasibility (ASL,pH-Weighted amine CEST, O2-Weighted SAGE-EPI)	pH-Weighted amine CEST	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.
Feasibility (ASL,pH-Weighted amine CEST, O2-Weighted SAGE-EPI)	Oxygen-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.

Primary Outcome Measures

Name	Time	Method
Change in oxygen-weighted SAGE-EPI to measure oxygen extraction (R2') before and after oxygen enrichment	Baseline and two hours 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.
Change in pH-weighted amine CEST MRI to measure tumor acidity (MTRasym at 3ppm) before/after oxygen enrichment	Baseline and two hours 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.
Tumor blood flow as measured by cerebral blood flow (CBF) from arterial spin labeling (ASL).	Baseline and two hours after Oxygen enrichment	Change in ASL perfusion estimates of relative cerebral blood flow (CBF) before and after oxygen enrichment

Trial Locations

Locations (1)

UCLA / Jonsson Comprehensive Cancer Center; 🇺🇸 Los Angeles, California, United States