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Trial Title:
Magnetic Resonance Imaging for Improving Knowledge of Brain Tumor Biology in Patients With Resectable Glioblastoma
NCT ID:
NCT06090903
Condition:
Glioblastoma
Recurrent Glioblastoma
Resectable Glioblastoma
Conditions: Official terms:
Glioblastoma
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Screening
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Biospecimen Collection
Description:
patients will receive 1-3 image-guided biopsies within tumor tissue already designated
for resection or removal.
Arm group label:
Screening (MRI)
Other name:
Biological Sample Collection
Other name:
Biospecimen Collected
Other name:
Specimen Collection
Intervention type:
Procedure
Intervention name:
Magnetic Resonance Imaging
Description:
Undergo MRI scan
Arm group label:
Screening (MRI)
Other name:
Magnetic Resonance
Other name:
Magnetic resonance imaging (procedure)
Other name:
Magnetic Resonance Imaging Scan
Other name:
Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance
Other name:
MR
Other name:
MR Imaging
Other name:
MRI
Other name:
MRI Scan
Other name:
NMR Imaging
Other name:
NMRI
Other name:
Nuclear Magnetic Resonance Imaging
Intervention type:
Other
Intervention name:
Medical Chart Review
Description:
Review Medical Chart
Arm group label:
Screening (MRI)
Other name:
Chart Review
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
UCLA / Jonsson Comprehensive Cancer Center
Address:
City:
Los Angeles
Zip:
90095
Country:
United States
Status:
Recruiting
Contact:
Last name:
Benjamin M. Ellingson
Phone:
310-481-7572
Email:
bellingson@mednet.ucla.edu
Investigator:
Last name:
Benjamin M. Ellingson
Email:
Principal Investigator
Start date:
April 14, 2022
Completion date:
April 18, 2028
Lead sponsor:
Agency:
Jonsson Comprehensive Cancer Center
Agency class:
Other
Collaborator:
Agency:
National Cancer Institute (NCI)
Agency class:
NIH
Source:
Jonsson Comprehensive Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06090903
