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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 14, 2021
Sponsor:
Information provided by (Responsible Party):
Jonsson Comprehensive Cancer Center

Tracking Information
First Submitted Date  ICMJE June 15, 2020
First Posted Date  ICMJE July 7, 2020
Last Update Posted Date July 14, 2021
Actual Study Start Date  ICMJE July 7, 2020
Estimated Primary Completion Date May 1, 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 6, 2020)
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Quantifying Oxygen Utilization of Tumors Using Oxygen-Enhanced Molecular MRI
Official Title  ICMJE Quantifying Tumor Respiration Using Oxygen-Enhanced Molecular MRI
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Malignant Brain Neoplasm
Intervention  ICMJE
  • 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
Study Arms  ICMJE 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.
Interventions:
  • Procedure: Arterial Spin Labeling Magnetic Resonance Imaging
  • Procedure: pH-Weighted amine CEST
  • Procedure: Oxygen-weighted SAGE-EPI
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 6, 2020)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 1, 2026
Estimated Primary Completion Date May 1, 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04460495
Other Study ID Numbers  ICMJE 20-000449
NCI-2020-03446 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jonsson Comprehensive Cancer Center
Study Sponsor  ICMJE Jonsson Comprehensive Cancer Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Benjamin M Ellingson UCLA / Jonsson Comprehensive Cancer Center
PRS Account Jonsson Comprehensive Cancer Center
Verification Date July 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP