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Simultaneous Multinuclear Metabolic MRI in Newly Diagnosed or Recurrent Glioma

Sponsor
Jonsson Comprehensive Cancer Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT05045027
Collaborator
United States Department of Defense (U.S. Fed)
60
Enrollment
1
Location
1
Arm
72.3
Anticipated Duration (Months)
0.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Biospecimen Collection
  • Procedure: Diagnostic Imaging
  • Procedure: Magnetic Resonance Imaging
 Early Phase 1

Detailed Description

PRIMARY OBJECTIVES:

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

  2. 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.

  3. 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 Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
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.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.
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Simultaneous Multinuclear (Na+/H+) Metabolic MRI in Brain Tumors
Actual Study Start Date :
Sep 1, 2021
Anticipated Primary Completion Date :
Sep 10, 2026
Anticipated Study Completion Date :
Sep 10, 2027

Arms and Interventions

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: Biospecimen Collection
Undergo collection of tissue samples
Other Names:
  • Biological Sample Collection

    • Procedure: Diagnostic Imaging
    Undergo multinuclear metabolic imaging
    Other Names:
  • Medical Imaging

    • Procedure: Magnetic Resonance Imaging
    Undergo MRI
    Other Names:
  • Magnetic Resonance Imaging Scan
  • Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance
  • MR Imaging
  • MRI
  • MRI Scan
  • NMR Imaging
  • NMRI
  • Nuclear Magnetic Resonance Imaging

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Total sodium concentration [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.

    2. NHE1 expression [Up to 5 years]

      Will create a comprehensive map of genes/pathways and unique cell subsets associated with NHE1 expression.

    3. Tumor metabolism [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 UCLA / Jonsson Comprehensive Cancer Center Los Angeles California United States 90095

    Sponsors and Collaborators

    • Jonsson Comprehensive Cancer Center
    • United States Department of Defense

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Jonsson Comprehensive Cancer Center
    ClinicalTrials.gov Identifier:
    NCT05045027
    Other Study ID Numbers:
    • 21-000514
    • NCI-2021-08698
    First Posted:
    Sep 16, 2021
    Last Update Posted:
    Sep 28, 2021
    Last Verified:
    Sep 1, 2021
    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
    Additional relevant MeSH terms:
    Glioma
    Recurrence

    Study Results

    No Results Posted as of Sep 28, 2021