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

NCT ID: NCT06090903

Last Updated: 2025-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-14

Study Completion Date

2028-04-18

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Glioblastoma Recurrent Glioblastoma Resectable Glioblastoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Screening (MRI)

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

Group Type EXPERIMENTAL

Biospecimen Collection

Intervention Type PROCEDURE

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

Magnetic Resonance Imaging

Intervention Type PROCEDURE

Undergo MRI scan

Medical Chart Review

Intervention Type OTHER

Review Medical Chart

Interventions

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Biospecimen Collection

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

Intervention Type PROCEDURE

Magnetic Resonance Imaging

Undergo MRI scan

Intervention Type PROCEDURE

Medical Chart Review

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Intervention Type OTHER

Other Intervention Names

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Biological Sample Collection Biospecimen Collected Specimen Collection 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 Chart Review

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Jonsson Comprehensive Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Benjamin M Ellingson

Role: PRINCIPAL_INVESTIGATOR

UCLA / Jonsson Comprehensive Cancer Center

Locations

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UCLA / Jonsson Comprehensive Cancer Center

Los Angeles, California, United States

Site Status RECRUITING

Countries

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United States

Facility Contacts

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Benjamin M. Ellingson

Role: primary

Other Identifiers

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NCI-2022-03536

Identifier Type: REGISTRY

Identifier Source: secondary_id

R01CA270027

Identifier Type: NIH

Identifier Source: secondary_id

View Link

21-002112

Identifier Type: -

Identifier Source: org_study_id