Simultaneous Multinuclear Metabolic MRI in Newly Diagnosed or Recurrent Glioma

September 27, 2023 updated by: Jonsson Comprehensive Cancer Center

Simultaneous Multinuclear (Na+/H+) Metabolic MRI in Brain Tumors

This clinical trial constructs and tests a novel multinuclear metabolic magnetic resonance imaging (MRI) sequence in patients with glioma (brain tumor) that is newly diagnosed or has come back (recurrent). This trial aims to develop new diagnostic imaging technology that may bridge gaps between early detection and diagnosis, prognosis, and treatment in brain cancer.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

PRIMARY OBJECTIVES:

I. Construct and test a novel multinuclear Na+-H+ metabolic MRI sequence with sensitivity to Sodium (Na+) concentration, Potential of Hydrogen (pH), and oxygen (O2).

II. Correlate Na+-, pH-, and O2-weighted MR image measurements with sodium-proton exchanger isoform-1 (NHE1) immunohistochemistry (IHC), bioenergetics, and gene expression using stereotactic image-guided biopsies from human brain tumors.

III. Quantify changes in Na+-, pH-, and O2-weighted MR images after neoadjuvant anti-PD-1 immunotherapy in recurrent glioblastoma (GBM) and explore associated changes in tumor biology.

OUTLINE:

AIM 1: Previous scan data from healthy subjects is collected and analyzed.

AIM 2: Patients undergo MRI. Patients also undergo collection of tissue samples for IHC analysis.

AIM 3: Patients undergo multinuclear metabolic imaging before and after immunotherapy and prior to surgical resection.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90095
        • Recruiting
        • UCLA / Jonsson Comprehensive Cancer Center
        • Contact:
        • Principal Investigator:
          • Benjamin M. Ellingson

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • AIM 1: Healthy volunteers with no evidence of brain tumors or neurologic disease
  • AIM 1: Age 18+
  • AIM 2: Newly diagnosed or recurrent suspected or confirmed glioma (low or high grade)
  • AIM 2: 10 IDH mutant and 10 IDH wild type gliomas
  • AIM 2: Clinically indicated for resective surgery or biopsy
  • AIM 2: Age 18+
  • AIM 2: Tumor size > 1x1x1 cm (measurable)
  • AIM 3: Recurrent glioma enrolled in an immunotherapy trial or clinically indicated to receive immunotherapy including anti-PD1
  • AIM 3: Age 18+

Exclusion Criteria:

  • AIM 1: Cannot safely perform an MRI
  • AIM 1: Age < 18
  • AIM 2: Cannot safely perform an MRI or use of MRI contrast agents
  • AIM 2: Age < 18
  • AIM 3: Cannot safely perform an MRI or use of MRI contrast agents
  • AIM 3: Age < 18

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Basic science (MRI, metabolic imaging, tissue collection)

AIM 1: Previous scan data from healthy subjects is collected and analyzed.

AIM 2: Patients undergo MRI. Patients also undergo collection of tissue samples for IHC analysis.

AIM 3: Patients undergo multinuclear metabolic imaging before and after immunotherapy and prior to surgical resection.
Procedure: Magnetic Resonance Imaging
Undergo MRI
Other Names:
  • MRI
  • Magnetic Resonance Imaging Scan
  • Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance
  • MR Imaging
  • MRI Scan
  • NMR Imaging
  • NMRI
  • Nuclear Magnetic Resonance Imaging
Procedure: Biospecimen Collection
Undergo collection of tissue samples
Other Names:
  • Biological Sample Collection
Procedure: Diagnostic Imaging
Undergo multinuclear metabolic imaging
Other Names:
  • Medical Imaging

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total sodium concentration
Time Frame: Up to 5 years
Will calculate NaT using standard methodology and normalize it to ocular Na+ concentration, a constant 135 mmol/l. Will then test whether healthy tissue has a coefficient of variance (COV) of < 10% across all 20 subjects.
Up to 5 years
NHE1 expression
Time Frame: Up to 5 years
Will create a comprehensive map of genes/pathways and unique cell subsets associated with NHE1 expression.
Up to 5 years
Tumor metabolism
Time Frame: Up to 5 years
Will examine the correlation between baseline tumor metabolism and change in metabolism with respect to overall survival using Cox multivariable regression.
Up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jonsson Comprehensive Cancer Center

Collaborators

United States Department of Defense

Investigators

  • Principal Investigator: Benjamin M Ellingson, UCLA / Jonsson Comprehensive Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2021

Primary Completion (Estimated)

September 10, 2026

Study Completion (Estimated)

September 10, 2027

Study Registration Dates

First Submitted

September 7, 2021

First Submitted That Met QC Criteria

September 7, 2021

First Posted (Actual)

September 16, 2021

Study Record Updates

Last Update Posted (Actual)

September 29, 2023

Last Update Submitted That Met QC Criteria

September 27, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21-000514
  • NCI-2021-08698 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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