GliomaEarly Phase 1NCT05045027
Simultaneous Multinuclear Metabolic MRI in Newly Diagnosed or Recurrent Glioma
A Early Phase 1 study testing Biospecimen Collection, Diagnostic Imaging and Magnetic Resonance Imaging in people with Glioma and Malignant Glioma, run by Jonsson Comprehensive Cancer Center at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Glioma, Malignant Glioma, Recurrent Glioma
- What is being tested?
- Biospecimen Collection, Diagnostic Imaging and Magnetic Resonance Imaging
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2021to 10 Sep 2027
- Phase
- Early Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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+
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- 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+
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California, 90095
About this study
Official title: 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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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.
- Conditions
- Glioma, Malignant Glioma, Recurrent Glioma, Recurrent Malignant Glioma
- Being tested
- Biospecimen Collection, Diagnostic Imaging, Magnetic Resonance Imaging
- Medical subject headings
- Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biospecimen CollectionProcedure or surgery
Also called Biological Sample Collection
Undergo collection of tissue samples
Diagnostic ImagingProcedure or surgery
Also called Medical Imaging
Undergo multinuclear metabolic imaging
Magnetic Resonance ImagingProcedure or surgery
Also called Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR Imaging, MRI
Undergo MRI
| Study group | Role | What they receive |
|---|---|---|
| Basic science (MRI, metabolic imaging, tissue collection) | Experimental | 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. Receives: Procedure: Biospecimen Collection; Procedure: Diagnostic Imaging; Procedure: Magnetic Resonance Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total sodium concentration
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.
Measured: Up to 5 years
NHE1 expression
Will create a comprehensive map of genes/pathways and unique cell subsets associated with NHE1 expression.
Measured: Up to 5 years
Tumor metabolism
Will examine the correlation between baseline tumor metabolism and change in metabolism with respect to overall survival using Cox multivariable regression.
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2021
- Study start1 Sep 2021
- Primary completion15 Nov 2023
- Study completion10 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GliomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jonsson Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Sponsor
- Investigators
- Benjamin M Ellingson, Principal investigator, UCLA / Jonsson Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05045027
- Sponsor's protocol ID
- 21-000514
- Other IDs
- NCI-2021-08698
- Status last verified
- Nov 2025
- First submitted
- 7 Sep 2021
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes