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Quantifying Oxygen Utilization of Tumors Using Oxygen-Enhanced Molecular MRI

Primary Purpose

Malignant Brain Neoplasm

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Arterial Spin Labeling Magnetic Resonance Imaging
pH-Weighted amine CEST
Oxygen-weighted SAGE-EPI
Sponsored by
Jonsson Comprehensive Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Malignant Brain Neoplasm

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • UCLA / Jonsson Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Feasibility (ASL,pH-Weighted amine CEST, O2-Weighted SAGE-EPI)

Arm Description

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.

Outcomes

Primary Outcome Measures

Change in pH-weighted amine CEST MRI to measure tumor acidity (MTRasym at 3ppm) before/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
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).
Change in ASL perfusion estimates of relative cerebral blood flow (CBF) before and after oxygen enrichment

Secondary Outcome Measures

Full Information

First Posted
June 15, 2020
Last Updated
May 4, 2022
Sponsor
Jonsson Comprehensive Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT04460495
Brief Title
Quantifying Oxygen Utilization of Tumors Using Oxygen-Enhanced Molecular MRI
Official Title
Quantifying Tumor Respiration Using Oxygen-Enhanced Molecular MRI
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Terminated
Why Stopped
insufficient accrual
Study Start Date
July 7, 2020 (Actual)
Primary Completion Date
September 16, 2021 (Actual)
Study Completion Date
September 16, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jonsson Comprehensive Cancer Center

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malignant Brain Neoplasm

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
oxygen-enhanced molecular MRI in healthy volunteers.
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Feasibility (ASL,pH-Weighted amine CEST, O2-Weighted SAGE-EPI)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Arterial Spin Labeling Magnetic Resonance Imaging
Other Intervention Name(s)
ARTERIAL SPIN LABELING FUNCTIONAL MRI, Arterial Spin Labeling MRI, ASL, ASL fMRI
Intervention Description
Undergo ASL scan
Intervention Type
Procedure
Intervention Name(s)
pH-Weighted amine CEST
Other Intervention Name(s)
Amine CEST, CEST-EPI
Intervention Description
Undergo pH Weighted amine CEST
Intervention Type
Procedure
Intervention Name(s)
Oxygen-weighted SAGE-EPI
Other Intervention Name(s)
SAGE-EPI, Hypoxia MRI
Intervention Description
Undergo Oxygen-weighted SAGE-EPI
Primary Outcome Measure Information:
Title
Change in pH-weighted amine CEST MRI to measure tumor acidity (MTRasym at 3ppm) before/after oxygen enrichment
Description
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.
Time Frame
Baseline and two hours after Oxygen enrichment
Title
Change in oxygen-weighted SAGE-EPI to measure oxygen extraction (R2') before and after oxygen enrichment
Description
We will perform voxel-wise t-tests via AFNI software between the average R2' and MTRasym during normal room air and medical grade air.
Time Frame
Baseline and two hours after Oxygen enrichment
Title
Tumor blood flow as measured by cerebral blood flow (CBF) from arterial spin labeling (ASL).
Description
Change in ASL perfusion estimates of relative cerebral blood flow (CBF) before and after oxygen enrichment
Time Frame
Baseline and two hours after Oxygen enrichment

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Benjamin M Ellingson
Organizational Affiliation
UCLA / Jonsson Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCLA / Jonsson Comprehensive Cancer Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Quantifying Oxygen Utilization of Tumors Using Oxygen-Enhanced Molecular MRI

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