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MRI for Brain Tumor
N/A
Recruiting
Led By Christina Cramer, MD
Research Sponsored by Wake Forest University Health Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Anticipated to receive 6 weeks of chemoradiation
≥18 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 months post-treatment
Awards & highlights
Study Summary
This trial is testing if PET scans, lumbar puncture, and blood tests can predict cognitive decline after radiation therapy.
Who is the study for?
This trial is for adults over 18 with high-grade glioma (grade III or IV) or specific grade II glioma, who are about to undergo 6 weeks of chemoradiation. They should be able to perform daily activities with varying degrees of assistance and must not have dementia, cognitive impairments before their tumor diagnosis, or be on cognition-enhancing drugs. Pregnant women and those unable to consent or fast before procedures are excluded.Check my eligibility
What is being tested?
The study aims to predict changes in brain function after radiation therapy using PET-MRI scans, blood tests, memory testing, and optional lumbar punctures. Researchers want to see if these methods can forecast who will experience significant declines in memory or attention due to the treatment.See study design
What are the potential side effects?
Participants may experience mild decreases in memory or attention following radiation therapy. The procedures like blood draws and lumbar punctures carry risks such as discomfort at the puncture site, bleeding, headache, infection risk at the needle insertion point.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am expected to undergo 6 weeks of combined chemotherapy and radiation treatment.
Select...
I am 18 years old or older.
Select...
My brain tumor is a high grade (III or IV) or a specific type of grade II.
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I can care for myself but may not be able to do heavy physical work.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4 months post-treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 months post-treatment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of Participants to Complete Cognitive Testing
Number of Participants to Complete Two PET scans
Secondary outcome measures
Change in Cerebrospinal Fluid Biomarkers Related to Cognitive Decline after Radiation Treatment
Change in PET measure Related to Cognitive Decline after Radiation Treatment
Trial Design
1Treatment groups
Experimental Treatment
Group I: PET-MRI In High-Grade Glioma Patients Undergoing ChemoradiationExperimental Treatment4 Interventions
PET scan and MRI scan of the brain, blood draw, and 1-hour of memory testing.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Blood draw
2021
Completed Phase 4
~6290
Find a Location
Who is running the clinical trial?
Wake Forest University Health SciencesLead Sponsor
1,240 Previous Clinical Trials
1,004,191 Total Patients Enrolled
Christina Cramer, MDPrincipal InvestigatorWake Forest Baptist Comprehensive Cancer Center
1 Previous Clinical Trials
6 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am unable to understand and agree to the study's details on my own.I am expected to undergo 6 weeks of combined chemotherapy and radiation treatment.I was diagnosed with dementia or mild cognitive impairment before my brain tumor diagnosis.I cannot speak or read English.I am 18 years old or older.My brain tumor is a high grade (III or IV) or a specific type of grade II.I can care for myself but may not be able to do heavy physical work.I am currently on medication to improve my memory or attention.I am on blood thinners but can join the main study, not the Lumbar Puncture part.
Research Study Groups:
This trial has the following groups:- Group 1: PET-MRI In High-Grade Glioma Patients Undergoing Chemoradiation
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.
What is the sample size of this research project?
"Affirmative. According to clinicaltrials.gov, the medical study which was launched on September 2nd 2022 is currently enrolling 16 participants from a single site. The details of this trial were last updated on September 6th 2022."
Answered by AI
Is there availability for interested participants in this research endeavor?
"Indeed, the information on clinicaltrials.gov affirms that this medical trial is currently seeking enrollees. This particular study was first announced on September 2nd 2022 and most recently revised on the 6th. The experiment requires 16 patients to be recruited at one site."
Answered by AI
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