Quantifying Oxygen Utilization of Tumors Using Oxygen-Enhanced Molecular MRI
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04460495 |
Recruitment Status :
Terminated
(insufficient accrual)
First Posted : July 7, 2020
Last Update Posted : May 10, 2022
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Malignant Brain Neoplasm | Procedure: Arterial Spin Labeling Magnetic Resonance Imaging Procedure: pH-Weighted amine CEST Procedure: Oxygen-weighted SAGE-EPI | Not Applicable |
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 Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 8 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Intervention Model Description: | oxygen-enhanced molecular MRI in healthy volunteers. |
Masking: | None (Open Label) |
Primary Purpose: | Other |
Official Title: | Quantifying Tumor Respiration Using Oxygen-Enhanced Molecular MRI |
Actual Study Start Date : | July 7, 2020 |
Actual Primary Completion Date : | September 16, 2021 |
Actual Study Completion Date : | September 16, 2021 |

Arm | Intervention/treatment |
---|---|
Experimental: 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.
|
Procedure: Arterial Spin Labeling Magnetic Resonance Imaging
Undergo ASL scan
Other Names:
Procedure: pH-Weighted amine CEST Undergo pH Weighted amine CEST
Other Names:
Procedure: Oxygen-weighted SAGE-EPI Undergo Oxygen-weighted SAGE-EPI
Other Names:
|
- Change in pH-weighted amine CEST MRI to measure tumor acidity (MTRasym at 3ppm) before/after oxygen enrichment [ Time Frame: 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.
- Change in oxygen-weighted SAGE-EPI to measure oxygen extraction (R2') before and after oxygen enrichment [ Time Frame: 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.
- Tumor blood flow as measured by cerebral blood flow (CBF) from arterial spin labeling (ASL). [ Time Frame: Baseline and two hours after Oxygen enrichment ]Change in ASL perfusion estimates of relative cerebral blood flow (CBF) before and after oxygen enrichment

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04460495
United States, California | |
UCLA / Jonsson Comprehensive Cancer Center | |
Los Angeles, California, United States, 90095 |
Principal Investigator: | Benjamin M Ellingson | UCLA / Jonsson Comprehensive Cancer Center |
Responsible Party: | Jonsson Comprehensive Cancer Center |
ClinicalTrials.gov Identifier: | NCT04460495 |
Other Study ID Numbers: |
20-000449 NCI-2020-03446 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ) |
First Posted: | July 7, 2020 Key Record Dates |
Last Update Posted: | May 10, 2022 |
Last Verified: | May 2022 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | Yes |
Brain Neoplasms Central Nervous System Neoplasms Nervous System Neoplasms Neoplasms by Site |
Neoplasms Brain Diseases Central Nervous System Diseases Nervous System Diseases |