Quantifying Oxygen Utilization of Tumors Using Oxygen-Enhanced Molecular MRI

NCT04460495 | Terminated

• 2 other identifiers: 20-000449NCI-2020-03446
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Malignant Brain Neoplasm

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (1)

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

EXPERIMENTAL

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; Procedure: pH-Weighted amine CEST; Procedure: Oxygen-weighted SAGE-EPI

Interventions

Arterial Spin Labeling Magnetic Resonance Imaging PROCEDURE

Undergo ASL scan

Also known as: ARTERIAL SPIN LABELING FUNCTIONAL MRI, Arterial Spin Labeling MRI, ASL, ASL fMRI

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

pH-Weighted amine CEST PROCEDURE

Undergo pH Weighted amine CEST

Also known as: Amine CEST, CEST-EPI

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

Oxygen-weighted SAGE-EPI PROCEDURE

Undergo Oxygen-weighted SAGE-EPI

Also known as: SAGE-EPI, Hypoxia MRI

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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Participants with contraindications to MRI including metal implants
• Participants who are deemed not able to or not safe to breath high concentrations of oxygen

Sponsors & Collaborators

• Jonsson Comprehensive Cancer Center: lead

Study Sites (1)

UCLA / Jonsson Comprehensive Cancer Center

Los Angeles, California, 90095, United States

Location

MeSH Terms

Conditions

Brain Neoplasms

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Benjamin M Ellingson

  UCLA / Jonsson Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: oxygen-enhanced molecular MRI in healthy volunteers.

Study Record Dates

• First Submitted: June 15, 2020
• First Posted: July 7, 2020
• Study Start: July 7, 2020
• Primary Completion: September 16, 2021
• Study Completion: September 16, 2021
• Last Updated: May 10, 2022

Record last verified: 2022-05

Locations

US (1)