Summary

Eligibility
for people ages 18 years and up (full criteria)
Healthy Volunteers
healthy people welcome
Location
at UCLA
Dates
study started
estimated completion
Principal Investigator
by Benjamin M Ellingson (ucla)

Description

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.

Official Title

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

Details

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.

Keywords

Glioma Malignant Glioma Recurrent Glioma Recurrent Malignant Glioma Biospecimen Collection Diagnostic Imaging Magnetic Resonance Imaging Basic science (MRI, metabolic imaging, tissue collection)

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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+

You CAN'T join if...

  • 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

Location

  • UCLA / Jonsson Comprehensive Cancer Center accepting new patients
    Los Angeles California 90095 United States

Lead Scientist at University of California Health

  • Benjamin M Ellingson (ucla)
    Professor, Radiological Sciences. Authored (or co-authored) 191 research publications.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Jonsson Comprehensive Cancer Center
ID
NCT05045027
Phase
Phase 1
Study Type
Interventional
Last Updated