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

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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06090903
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Jonsson Comprehensive Cancer Center
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Benjamin M Ellingson
Principal Investigator Affiliation	UCLA / Jonsson Comprehensive Cancer Center
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other, NIH
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Glioblastoma, Recurrent Glioblastoma, Resectable Glioblastoma

Additional Details

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.

Arms & Interventions

Arms

Experimental: Screening (MRI)

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Los Angeles, California

Status

Recruiting

Address

UCLA / Jonsson Comprehensive Cancer Center

Los Angeles, California, 90095

Site Contact

Benjamin M. Ellingson

[email protected]

310-481-7572