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Quantifying Oxygen Utilization of Tumors Using Oxygen-Enhanced Molecular MRI

Quantifying Tumor Respiration Using Oxygen-Enhanced Molecular MRI

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04460495
Enrollment
8
Registered
2020-07-07
Start date
2020-07-07
Completion date
2021-09-16
Last updated
2022-05-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malignant Brain Neoplasm

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.

Interventions

PROCEDUREpH-Weighted amine CEST

Undergo pH Weighted amine CEST

PROCEDUREOxygen-weighted SAGE-EPI

Undergo Oxygen-weighted SAGE-EPI

Sponsors

Jonsson Comprehensive Cancer Center
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Intervention model description

oxygen-enhanced molecular MRI in healthy volunteers.

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Change in pH-weighted amine CEST MRI to measure tumor acidity (MTRasym at 3ppm) before/after oxygen enrichmentBaseline and two hours after Oxygen enrichmentWill 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 enrichmentBaseline and two hours after Oxygen enrichmentWe 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).Baseline and two hours after Oxygen enrichmentChange in ASL perfusion estimates of relative cerebral blood flow (CBF) before and after oxygen enrichment

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026