Quantifying Oxygen Utilization of Tumors Using Oxygen-Enhanced Molecular MRI

Quantifying Tumor Respiration Using Oxygen-Enhanced Molecular MRI

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.

Study Overview

• Status: Terminated
• Conditions: Malignant Brain Neoplasm
• Intervention / Treatment: Procedure: Arterial Spin Labeling Magnetic Resonance Imaging; Procedure: pH-Weighted amine CEST; Procedure: Oxygen-weighted SAGE-EPI

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: Interventional
• Enrollment (Actual): 8
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90095
      • UCLA / Jonsson Comprehensive Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline and two hours after Oxygen enrichment
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.	Baseline and two hours after Oxygen enrichment
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	Baseline and two hours after Oxygen enrichment

Collaborators and Investigators

• Sponsor: Jonsson Comprehensive Cancer Center

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 7, 2020
• Primary Completion (ACTUAL): September 16, 2021
• Study Completion (ACTUAL): September 16, 2021

Study Registration Dates

• First Submitted: June 15, 2020
• First Submitted That Met QC Criteria: July 6, 2020
• First Posted (ACTUAL): July 7, 2020

Study Record Updates

• Last Update Posted (ACTUAL): May 10, 2022
• Last Update Submitted That Met QC Criteria: May 4, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms; Neoplasms by Site; Central Nervous System Neoplasms; Nervous System Neoplasms; Brain Neoplasms
• Other Study ID Numbers: 20-000449; NCI-2020-03446 (REGISTRY: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• 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