Clinical trial NCT04460495: Quantifying Oxygen Utilization of Tumors Using Oxygen-Enhanced Molecular MRI
Official title: Quantifying Tumor Respiration Using Oxygen-Enhanced Molecular MRI
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Malignant Brain Neoplasm
Lead sponsor: Jonsson Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2020-07-07
Enrollment: 8
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: oxygen-enhanced molecular MRI in healthy volunteers.
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Change in pH-weighted amine CEST MRI to measure tumor acidity (MTRasym at 3ppm) before/after oxygen enrichment
timeFrame: Baseline and two hours after Oxygen enrichment
measure: Change in oxygen-weighted SAGE-EPI to measure oxygen extraction (R2') before and after oxygen enrichment
timeFrame: Baseline and two hours after Oxygen enrichment
measure: Tumor blood flow as measured by cerebral blood flow (CBF) from arterial spin labeling (ASL).
timeFrame: Baseline and two hours after Oxygen enrichment
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA / Jonsson Comprehensive Cancer Center
state: California
Study officials:
affiliation: UCLA / Jonsson Comprehensive Cancer Center
name: Benjamin M Ellingson
role: PRINCIPAL_INVESTIGATOR
References: