Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04460495
Recruitment Status : Recruiting
First Posted : July 7, 2020
Last Update Posted : July 23, 2020
Sponsor:
Information provided by (Responsible Party):
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.

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

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 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
Estimated Primary Completion Date : May 1, 2025
Estimated Study Completion Date : May 1, 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oxygen Therapy

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:
  • ARTERIAL SPIN LABELING FUNCTIONAL MRI
  • Arterial Spin Labeling MRI
  • ASL
  • ASL fMRI

Procedure: pH-Weighted amine CEST
Undergo pH Weighted amine CEST
Other Names:
  • Amine CEST
  • CEST-EPI

Procedure: Oxygen-weighted SAGE-EPI
Undergo Oxygen-weighted SAGE-EPI
Other Names:
  • SAGE-EPI
  • Hypoxia MRI




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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



Information from the National Library of Medicine

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.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

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


Locations
Layout table for location information
United States, California
UCLA / Jonsson Comprehensive Cancer Center Recruiting
Los Angeles, California, United States, 90095
Contact: Benjamin M. Ellingson    310-481-7572    bellingson@mednet.ucla.edu   
Principal Investigator: Benjamin M. Ellingson         
Sponsors and Collaborators
Jonsson Comprehensive Cancer Center
Investigators
Layout table for investigator information
Principal Investigator: Benjamin M Ellingson UCLA / Jonsson Comprehensive Cancer Center
Layout table for additonal information
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) )
20-000449 ( Other Identifier: UCLA / Jonsson Comprehensive Cancer Center )
First Posted: July 7, 2020    Key Record Dates
Last Update Posted: July 23, 2020
Last Verified: July 2020

Layout table for additional information
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
Additional relevant MeSH terms:
Layout table for MeSH terms
Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases