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

NCT06090903 | Recruiting DMC FDA Device

• 3 other identifiers: 21-002112NCI-2022-03536R01CA270027
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Glioblastoma; Recurrent Glioblastoma; Resectable Glioblastoma

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (1)

• DCN protein concentration in blood plasma

  Up to 5 years

Study Arms (1)

Screening (MRI)

EXPERIMENTAL

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

Procedure: Biospecimen Collection; Procedure: Magnetic Resonance Imaging; Other: Medical Chart Review

Interventions

Biospecimen Collection PROCEDURE

patients will receive 1-3 image-guided biopsies within tumor tissue already designated for resection or removal.

Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection

Screening (MRI)

Magnetic Resonance Imaging PROCEDURE

Undergo MRI scan

Also known as: Magnetic Resonance, Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR, MR Imaging, MRI, MRI Scan, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging

Screening (MRI)

Medical Chart Review OTHER

Review Medical Chart

Also known as: Chart Review

Screening (MRI)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Jonsson Comprehensive Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

UCLA / Jonsson Comprehensive Cancer Center

Los Angeles, California, 90095, United States

RECRUITING

MeSH Terms

Conditions

Glioblastoma

Interventions

Specimen Handling; Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Spectrum Analysis; Chemistry Techniques, Analytical

Study Officials

• Benjamin M Ellingson

  UCLA / Jonsson Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2023
• First Posted: October 19, 2023
• Study Start: April 14, 2022
• Primary Completion (Estimated): April 18, 2027
• Study Completion (Estimated): April 18, 2028
• Last Updated: November 10, 2025

Record last verified: 2025-11

Locations

US (1)