Magnetic Resonance Imaging for Improving Knowledge of Brain Tumor Biology in Patients With Resectable Glioblastoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Biospecimen Collection, Magnetic Resonance Imaging, Medical Chart Review.
- Who it may be relevant to
- Registry conditions: Glioblastoma, Recurrent Glioblastoma, Resectable Glioblastoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Exploration Into the Association Between Decorin (DCN) Expression and MR Phenotypes in GBM
Overview
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
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.
Interventions
- Procedure Biospecimen Collection
patients will receive 1-3 image-guided biopsies within tumor tissue already designated for resection or removal. - Procedure Magnetic Resonance Imaging
Undergo MRI scan - Other Medical Chart Review
Review Medical Chart
Primary outcome measures
- Decorin (DCN) expression [Time frame: Up to 5 years]
- DCN expression correlated to ADCL [Time frame: Up to 5 years]
- Incidence of tumors with high diffusion measurements among MES-like cells [Time frame: Up to 5 years]
- DCN expression among Mesenchymal-Like (MES-like) cells [Time frame: Up to 5 years]
Secondary outcome measures (1)
- DCN protein concentration in blood plasma [Time frame: Up to 5 years]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Screening
Study locations
United States · 1 center
- UCLA / Jonsson Comprehensive Cancer Center — Los Angeles
Identifiers
NCT: NCT06090903 · 21-002112 · NCI-2022-03536 · R01CA270027