Quantifying Oxygen Utilization of Tumors Using Oxygen-Enhanced Molecular MRI

Malignant Brain Neoplasm Clinical Trial

Official title:

Quantifying Tumor Respiration Using Oxygen-Enhanced Molecular MRI

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04460495
• Other study ID #: 20-000449
• Secondary ID: NCI-2020-03446
• Status: Terminated
• Phase: N/A
• Start date: July 7, 2020
• Est. completion date: September 16, 2021

Study information

• Verified date: May 2022
• Source: Jonsson Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: September 16, 2021
• Est. primary completion date: September 16, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Neoplasms
• Malignant Brain Neoplasm

Intervention

Procedure:
• Arterial Spin Labeling Magnetic Resonance Imaging
Undergo ASL scan
• pH-Weighted amine CEST
Undergo pH Weighted amine CEST
• Oxygen-weighted SAGE-EPI
Undergo Oxygen-weighted SAGE-EPI

Locations

Country	Name	City	State
United States	UCLA / Jonsson Comprehensive Cancer Center	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Jonsson Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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