Clinical trial NCT05045027: Simultaneous Multinuclear Metabolic MRI in Newly Diagnosed or Recurrent Glioma
Official title: Simultaneous Multinuclear (Na+/H+) Metabolic MRI in Brain Tumors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Glioma
Malignant Glioma
Recurrent Glioma
Recurrent Malignant Glioma
Lead sponsor: Jonsson Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
First posted: 2021-09-16
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
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.
Primary purpose: BASIC_SCIENCE

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.

Eligibility 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

Primary outcomes:
measure: Total sodium concentration
timeFrame: Up to 5 years
measure: NHE1 expression
timeFrame: Up to 5 years
measure: Tumor metabolism
timeFrame: Up to 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA / Jonsson Comprehensive Cancer Center
state: California
Study officials:
affiliation: UCLA / Jonsson Comprehensive Cancer Center
name: Benjamin M Ellingson
role: PRINCIPAL_INVESTIGATOR
References: