Simultaneous Multinuclear Metabolic MRI in Newly Diagnosed or Recurrent Glioma

Jonsson Comprehensive Cancer Center

Status and phase: Active, not recruiting; Early Phase 1

Conditions: Glioma; Recurrent Malignant Glioma; Malignant Glioma; Recurrent Glioma

Treatments: Procedure: Diagnostic Imaging; Procedure: Magnetic Resonance Imaging; Procedure: Biospecimen Collection

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT05045027

NCI-2021-08698 (Registry Identifier)

21-000514

Details and patient eligibility

About

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.

Full 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.

Enrollment: 36 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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36 participants in 1 patient group

Basic science (MRI, metabolic imaging, tissue collection)

Experimental group

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.

Treatment:

Procedure: Magnetic Resonance Imaging

Procedure: Biospecimen Collection

Procedure: Diagnostic Imaging