Quantifying Oxygen Utilization of Tumors Using Oxygen-Enhanced Molecular MRI
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|ClinicalTrials.gov Identifier: NCT04460495|
Recruitment Status : Recruiting
First Posted : July 7, 2020
Last Update Posted : July 23, 2020
|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|
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.
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)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||oxygen-enhanced molecular MRI in healthy volunteers.|
|Masking:||None (Open Label)|
|Official Title:||Quantifying Tumor Respiration Using Oxygen-Enhanced Molecular MRI|
|Actual Study Start Date :||July 7, 2020|
|Estimated Primary Completion Date :||May 1, 2025|
|Estimated Study Completion Date :||May 1, 2026|
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
Procedure: pH-Weighted amine CEST
Undergo pH Weighted amine CEST
Procedure: Oxygen-weighted SAGE-EPI
Undergo Oxygen-weighted SAGE-EPI
- 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
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||Recruiting|
|Los Angeles, California, United States, 90095|
|Contact: Benjamin M. Ellingson 310-481-7572 firstname.lastname@example.org|
|Principal Investigator: Benjamin M. Ellingson|
|Principal Investigator:||Benjamin M Ellingson||UCLA / Jonsson Comprehensive Cancer Center|