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Clinical Trials/NCT04460495
NCT04460495
Terminated
Not Applicable

Quantifying Tumor Respiration Using Oxygen-Enhanced Molecular MRI

Jonsson Comprehensive Cancer Center1 site in 1 country8 target enrollmentJuly 7, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Malignant Brain Neoplasm
Sponsor
Jonsson Comprehensive Cancer Center
Enrollment
8
Locations
1
Primary Endpoint
Change in oxygen-weighted SAGE-EPI to measure oxygen extraction (R2') before and after oxygen enrichment
Status
Terminated
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 7, 2020
End Date
September 16, 2021
Last Updated
3 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

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.

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.

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

Study Sites (1)

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