Ignite Creation Date:
2025-12-24 @ 7:18 PM
Ignite Modification Date:
2025-12-30 @ 6:51 AM
Study NCT ID:
NCT06090903
Status:
RECRUITING
Last Update Posted:
2025-11-10
First Post:
2023-10-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Magnetic Resonance Imaging for Improving Knowledge of Brain Tumor Biology in Patients With Resectable Glioblastoma
Sponsor:
Jonsson Comprehensive Cancer Center
Organization:
Study Overview
Official Title:
Exploration Into the Association Between Decorin (DCN) Expression and MR Phenotypes in GBM
Status:
RECRUITING
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2022-03536 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View | |
| R01CA270027 | NIH | None | https://reporter.nih.gov/quic… | View |