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Clinical Trials/NCT06090903
NCT06090903RecruitingNot Applicable

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

Jonsson Comprehensive Cancer Center2 sites in 1 country50 target enrollmentStarted: April 14, 2022Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
50
Locations
2
Primary Endpoint
Incidence of tumors with high diffusion measurements among MES-like cells

Study Overview

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:

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Screening
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

Incidence of tumors with high diffusion measurements among MES-like cells

Time Frame: Up to 5 years

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.

Decorin (DCN) expression

Time Frame: Up to 5 years

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.

DCN expression correlated to ADCL

Time Frame: Up to 5 years

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.

DCN expression among Mesenchymal-Like (MES-like) cells

Time Frame: Up to 5 years

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.

Secondary Outcomes

  • DCN protein concentration in blood plasma(Up to 5 years)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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