Glioma, Malignant Glioma, Recurrent Glioma, Recurrent Malignant Glioma
Conditions
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.
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.
Interventions
PROCEDUREBiospecimen Collection
Undergo collection of tissue samples
PROCEDUREDiagnostic Imaging
Undergo multinuclear metabolic imaging
PROCEDUREMagnetic Resonance Imaging
Undergo MRI
Sponsors
United States Department of Defense
Jonsson Comprehensive Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| NHE1 expression | Up to 5 years | Will create a comprehensive map of genes/pathways and unique cell subsets associated with NHE1 expression. |
| 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. |
Countries
United States
Outcome results
None listed