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Simultaneous Multinuclear Metabolic MRI in Newly Diagnosed or Recurrent Glioma

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ClinicalTrials.gov Identifier: NCT05045027
Recruitment Status : Recruiting
First Posted : September 16, 2021
Last Update Posted : September 28, 2022
Sponsor:
Collaborator:
United States Department of Defense
Information provided by (Responsible Party):
Jonsson Comprehensive Cancer Center

Study Description
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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
Glioma Malignant Glioma Recurrent Glioma Recurrent Malignant Glioma Procedure: Biospecimen Collection Procedure: Diagnostic Imaging Procedure: Magnetic Resonance Imaging Early Phase 1

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated 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.
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Simultaneous Multinuclear (Na+/H+) Metabolic MRI in Brain Tumors
Actual Study Start Date : September 1, 2021
Estimated Primary Completion Date : September 10, 2026
Estimated Study Completion Date : September 10, 2027

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 Name: Biological Sample Collection

Procedure: Diagnostic Imaging
Undergo multinuclear metabolic imaging
Other Name: 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
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Primary Outcome Measures :
  1. 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.

  2. NHE1 expression [ Time Frame: Up to 5 years ]
    Will create a comprehensive map of genes/pathways and unique cell subsets associated with NHE1 expression.

  3. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05045027


Contacts
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Contact: Halah Mansour 310-794-5380 halahmansour@mednet.ucla.edu
Contact: Saima Chaabane 310-794-8995 schaabane@mednet.ucla.edu

Locations
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United States, California
UCLA / Jonsson Comprehensive Cancer Center Recruiting
Los Angeles, California, United States, 90095
Contact: Halah Mansour    310-794-5380    halahmansour@mednet.ucla.eduCLA.EDU   
Principal Investigator: Benjamin M. Ellingson         
Sponsors and Collaborators
Jonsson Comprehensive Cancer Center
United States Department of Defense
Investigators
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Principal Investigator: Benjamin M Ellingson UCLA / Jonsson Comprehensive Cancer Center
More Information
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Responsible Party: Jonsson Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT05045027    
Other Study ID Numbers: 21-000514
NCI-2021-08698 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
First Posted: September 16, 2021    Key Record Dates
Last Update Posted: September 28, 2022
Last Verified: September 2022

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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:
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Glioma
Recurrence
Disease Attributes
Pathologic Processes
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
 Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue