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

Jonsson Comprehensive Cancer Center logo

Jonsson Comprehensive Cancer Center

Status

Enrolling

Conditions

Glioblastoma
Recurrent Glioblastoma
Resectable Glioblastoma

Treatments

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

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT06090903
NCI-2022-03536 (Registry Identifier)
21-002112
R01CA270027 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment

50 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Screening

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

50 participants in 1 patient group

Screening (MRI)
Experimental group
Description:
Patients undergo one MRI scan over approximately 1 hour prior to surgery.
Treatment:
Other: Medical Chart Review
Procedure: Magnetic Resonance Imaging
Procedure: Biospecimen Collection

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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