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ASL-MRI for Glioblastoma Treatment Assessment
N/A
Recruiting
Led By Ananth Madhuranthakam, PhD
Research Sponsored by University of Texas Southwestern Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Scheduled to undergo chemoradiation
Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights
Study Summary
This trial will use MRI to study how well a treatment for glioblastoma works.
Who is the study for?
This trial is for patients with newly diagnosed Glioblastoma (GBM) who haven't started treatment. They must be in good enough health to perform daily activities, not have severe allergies to MRI contrast agents, and women must not be pregnant. It's also important that participants don't have any metal devices or conditions that make MRI unsafe.Check my eligibility
What is being tested?
The study tests how well a special type of MRI scan called Arterial Spin Labeling (ASL) can track the effectiveness of GBM treatments over time. Participants will undergo seven additional ASL-MRI scans before, during, and after their standard therapy to monitor changes in brain perfusion.See study design
What are the potential side effects?
MRI with ASL is generally safe but may cause discomfort due to the length of time spent in the scanner. There's a small risk of allergic reaction to gadolinium if used, though this trial avoids it. Claustrophobia or back pain could worsen due to lying still during scanning.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am scheduled for combined chemotherapy and radiation treatment.
Select...
I am able to care for myself and perform daily activities.
Select...
I have been diagnosed with glioblastoma multiforme (GBM).
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in perfusion within enhancing tumor
Progression Free Survival (PFS)
Secondary outcome measures
ASL measured perfusion within enhancing tumor
Overall Survival (OS)
Trial Design
1Treatment groups
Experimental Treatment
Group I: Glioblastoma PatientsExperimental Treatment1 Intervention
Patients with histologically proven glioblastoma will undergo enhanced MRI with arterial spin labeling at weeks 0, 3, 6, 10, 18, 26, and 34 after beginning standard of care treatment.
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Who is running the clinical trial?
University of Texas Southwestern Medical CenterLead Sponsor
1,051 Previous Clinical Trials
1,054,719 Total Patients Enrolled
2 Trials studying Glioblastoma
30 Patients Enrolled for Glioblastoma
Ananth Madhuranthakam, PhDPrincipal Investigator - UT Southwestern Medical Center
University of Texas Southwestern Medical Center
1 Previous Clinical Trials
40 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I cannot undergo an MRI due to severe claustrophobia, back pain, or uncontrollable tremors.I have a new diagnosis of GBM and haven't started treatment beyond surgery.I am a woman who can become pregnant and agree to a pregnancy test before imaging.I am scheduled for combined chemotherapy and radiation treatment.You have had a serious allergic reaction to Gadolinium-based contrast agents in the past.I have had chemotherapy or radiotherapy before.I am not pregnant.I am able to care for myself and perform daily activities.I have been diagnosed with glioblastoma multiforme (GBM).I have sickle cell disease or another condition that causes low red blood cell count.
Research Study Groups:
This trial has the following groups:- Group 1: Glioblastoma Patients
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are new enrollees still being sought for this experiment?
"According to the public clinicaltrials.gov database, this clinical trial is currently recruiting patients. The listing was first posted on April 16th, 2019 and was last updated on October 6th, 2020."
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