Magnetic Resonance Imaging for Improving Knowledge of Brain Tumor Biology in Patients With Resectable Glioblastoma

Exploration Into the Association Between Decorin (DCN) Expression and MR Phenotypes in GBM

This clinical trial uses a type of imaging scan called magnetic resonance imaging (MRI) to study brain tumor biology in patients with glioblastoma that can be removed by surgery (resectable). Malignant gliomas are the second leading cause of cancer mortality in people under the age of 35 in the United States. Glioblastoma is a type of malignant glioma with very poor patient prognosis. There are currently only about 3 drugs approved by the Food and Drug Administration (FDA) for the treatment of glioblastoma, one of them being administration of bevacizumab, which is very expensive. It is the most widely used treatment for glioblastoma with dramatic results. However, previous clinical trials have not demonstrated an overall survival benefit across all patient populations with glioblastoma that has returned after treatment (recurrent). The study aims to identify which patients who will benefit from bevacizumab therapy by observing MRI images and corresponding imaging biomarkers.

Study Overview

• Status: Recruiting
• Conditions: Glioblastoma; Recurrent Glioblastoma; Resectable Glioblastoma
• Intervention / Treatment: Procedure: Magnetic Resonance Imaging; Procedure: Biospecimen Collection; Other: Medical Chart Review

Detailed Description

PRIMARY OBJECTIVES:

I. Enhancing tumors with high diffusion measurements (low apparent diffusion coefficient [ADCL] > 1.24 um^2/ms) will have higher DCN protein expression compared with tumors exhibiting low diffusion measurements (ADCL < 1.24 um^2/ms.) (Aim 1A) II. Enhancing tumors with high diffusion measurements (low apparent diffusion coefficient [ADCL] > 1.24 um^2/ms) will have higher deoxyribonucleic acid (DNA) expression compared with tumors exhibiting low diffusion measurements (ADCL < 1.24 um^2/ms.) (Aim 1B) III. Enhancing tumors with high diffusion measurements (low apparent diffusion coefficient [ADCL] > 1.24 um^2/ms) will have higher ribonucleic acid (RNA) expression compared with tumors exhibiting low diffusion measurements (ADCL < 1.24 um^2/ms.) (Aim 1C) IV. Mesenchymal-Like (MES-like) cells will have higher frequency of incidence of tumors with high diffusion measurements (ADCL > 1.24 um^2/ms) and higher overall DCN expression levels compared to other genotypes.

SECONDARY OBJECTIVE:

I. DCN immunohistochemistry (IHC), in-situ hybridization (ISH), and RNA expression within the tumor will be linearly correlated with continuous values of diffusion measurements (ADCL).

OUTLINE:

Patients undergo one MRI scan over approximately 1 hour prior to surgery.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90095
      • Recruiting
      • UCLA / Jonsson Comprehensive Cancer Center
      • Principal Investigator: Benjamin M. Ellingson
      • Contact: Benjamin M. Ellingson; Phone Number: 310-481-7572; Email: bellingson@mednet.ucla.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients > 18 years of age
• Patients with newly diagnosed, suspected or recurrent glioblastoma (GBM) patients with enhancing tumors greater than 1.5 mL clinically indicated for surgical resection. Recurrent GBM must have occurred more than 3 months after the end of radiation therapy per Response Assessment in Neuro-Oncology Criteria (RANO) guidelines

Exclusion Criteria:

• Counterindication to magnetic resonance imaging (MRI) (Patient has a pacemaker or metal in the body)
• Patients < 18 years of age

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Screening (MRI); Patients undergo one MRI scan over approximately 1 hour prior to surgery.

Procedure: Magnetic Resonance Imaging; Undergo MRI scan; Other Names: MRI; Magnetic Resonance; Magnetic Resonance Imaging Scan; Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance; MR; MR Imaging; MRI Scan; NMR Imaging; NMRI; Nuclear Magnetic Resonance Imaging; Magnetic resonance imaging (procedure); Procedure: Biospecimen Collection; patients will receive 1-3 image-guided biopsies within tumor tissue already designated for resection or removal.; Other Names: Biological Sample Collection; Biospecimen Collected; Specimen Collection; Other: Medical Chart Review; Review Medical Chart; Other Names: Chart Review

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Decorin (DCN) expression	Will use a two-sided t-test to compare DCN immunohistochemistry (IHC), in-situ hybridization (ISH), and ribonucleic acid (RNA) sequencing positivity between low apparent diffusion coefficient (ADCL) < 1.24 um^2/ms and ADCL > 1.24 um2/ms groups.	Up to 5 years
DCN expression correlated to ADCL	Will assess whether DCN IHC, ISH, and RNA expression within the tumor is linearly correlated with continuous values of ADCL. To test this, will examine Pearson's correlation coefficient (R^2) and test whether the slope of the linear regression line is significantly different from zero. After purification, will also quantify the particular genotype or cell states represented by tumor cells for each ADCL phenotype.	Up to 5 years
Incidence of tumors with high diffusion measurements among MES-like cells	Will assess whether MES-like cells have higher frequency of incidence of ADCL > 1.24 um^2/ms compared to other genotypes. To test this, will use a chi-squared goodness of fit test to assess the frequency of observations and an analysis of variance (ANOVA) to look at DCN protein, deoxyribonucleic acid (DNA), and RNA expression between genotypes.	Up to 5 years
DCN expression among Mesenchymal-Like (MES-like) cells	Will assess whether MES-like cells have higher overall DCN expression levels compared to other genotypes. To test this, will use a chi-squared goodness of fit test to assess the frequency of observations and an ANOVA to look at DCN protein, DNA, and RNA expression between genotypes.	Up to 5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
DCN protein concentration in blood plasma	Will compare DCN protein concentration in blood plasma and use a two-sided t-test to compare DCN concentration between ADCL < 1.24 um^2/ms and ADCL > 1.24 um^2/ms cohorts. We will also test whether blood plasma concentrations of DCN are linearly correlated with tumor IHC levels using Pearson's correlation coefficient (R^2) and test whether the slope of the linear regression line is significantly different from zero.	Up to 5 years

Collaborators and Investigators

• Sponsor: Jonsson Comprehensive Cancer Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Benjamin M Ellingson, UCLA / Jonsson Comprehensive Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): April 14, 2022
• Primary Completion (Estimated): April 18, 2027
• Study Completion (Estimated): April 18, 2028

Study Registration Dates

• First Submitted: October 13, 2023
• First Submitted That Met QC Criteria: October 13, 2023
• First Posted (Actual): October 19, 2023

Study Record Updates

• Last Update Posted (Actual): November 10, 2025
• Last Update Submitted That Met QC Criteria: November 6, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Glioblastoma; Investigative Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Chemistry Techniques, Analytical; Spectrum Analysis; Specimen Handling; Magnetic Resonance Spectroscopy
• Other Study ID Numbers: 21-002112; NCI-2022-03536 (Registry Identifier: CTRP (Clinical Trial Reporting Program)); R01CA270027 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No