Simultaneous Multinuclear Metabolic MRI in Newly Diagnosed or Recurrent Glioma

Glioma Clinical Trial

Official title:

Simultaneous Multinuclear (Na+/H+) Metabolic MRI in Brain Tumors

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05045027
• Other study ID #: 21-000514
• Secondary ID: NCI-2021-08698
• Status: Recruiting
• Phase: Early Phase 1
• Start date: September 1, 2021
• Est. completion date: September 10, 2027

Study information

• Verified date: September 2023
• Source: Jonsson Comprehensive Cancer Center
• Contact: Halah Mansour
• Phone: 310-794-5380
• Email: halahmansour[@]mednet.ucla.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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). This trial aims to develop new diagnostic imaging technology that may bridge gaps between early detection and diagnosis, prognosis, and treatment in brain cancer.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: September 10, 2027
• Est. primary completion date: September 10, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Glioma
• Malignant Glioma
• Recurrence
• Recurrent Glioma
• Recurrent Malignant Glioma

Intervention

Procedure:
• Biospecimen Collection
Undergo collection of tissue samples
• Diagnostic Imaging
Undergo multinuclear metabolic imaging
• Magnetic Resonance Imaging
Undergo MRI

Locations

Country	Name	City	State
United States	UCLA / Jonsson Comprehensive Cancer Center	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
Jonsson Comprehensive Cancer Center	United States Department of Defense

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Up to 5 years
Primary	NHE1 expression	Will create a comprehensive map of genes/pathways and unique cell subsets associated with NHE1 expression.	Up to 5 years
Primary	Tumor metabolism	Will examine the correlation between baseline tumor metabolism and change in metabolism with respect to overall survival using Cox multivariable regression.	Up to 5 years