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Advanced Imaging and Biopsy Techniques for Brain Tumor (ReGIT Trial)
Phase < 1
Recruiting
Led By Jason Parker, PhD
Research Sponsored by Indiana University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Subject is between 18 and 89 years of age
Subject has radiologically-diagnosed or suspected WHO Grade II-IV glioma based on physician review or conformance with published WHO criteria as evaluated by the PI
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 1 year.
Awards & highlights
ReGIT Trial Summary
This trial is studying how brain tumors might change over time and whether newer brain imaging tools like MRI and PET can predict these changes.
Who is the study for?
This trial is for adults aged 18-89 with a newly diagnosed Grade II-IV glioma brain tumor, who can lay still for imaging tests and are planning surgery to remove the tumor. They must be able to read/write in English and not have any conditions that prevent MRI scans.Check my eligibility
What is being tested?
The study examines how brain tumors change over time using advanced imaging techniques like MRI/PET scans combined with biopsies. It aims to see if these tools can predict genetic mutations in the tumors.See study design
What are the potential side effects?
Potential side effects may include discomfort from lying still during long imaging sessions, reactions to contrast agents used in MRIs (like allergic reactions or kidney problems), and risks associated with biopsy procedures.
ReGIT Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 89 years old.
Select...
My brain tumor is suspected or confirmed to be Grade II-IV glioma.
Select...
I have not received any treatment for my condition yet.
Select...
There is enough of my tumor to take at least 2 biopsy samples during surgery.
Select...
I can stay still during MRI scans.
Select...
I am scheduled for surgery to remove and biopsy my brain tumor.
ReGIT Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, an average of 1 year.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 1 year.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Classification sensitivity
Secondary outcome measures
A list of which scans are necessary for statistically valid routine clinical classification of genomic abnormalities.
Accuracy of the mathematical algorithms to predict progression-free survival (PFS) and overall survival (OS).
ReGIT Trial Design
1Treatment groups
Experimental Treatment
Group I: Baseline Imaging and BiopsyExperimental Treatment5 Interventions
Subjects will receive a PET-CT with the radiopharmaceuticals FET and O-15 Water (under RDRC approval for basic research) prior to their standard of care neurosurgery via stereotactic core biopsy. Research samples will be collected for analysis intraoperatively.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
CT scan
2017
Completed Phase 2
~2360
Find a Location
Who is running the clinical trial?
Indiana UniversityLead Sponsor
980 Previous Clinical Trials
983,256 Total Patients Enrolled
Children's Hospital of PhiladelphiaOTHER
708 Previous Clinical Trials
8,581,039 Total Patients Enrolled
Jason Parker, PhDPrincipal InvestigatorIndiana University
2 Previous Clinical Trials
20 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have kidney issues and can't follow certain medication dosing due to my weight.I am between 18 and 89 years old.My brain tumor is suspected or confirmed to be Grade II-IV glioma.I can lay on my back for up to 80 minutes.I have not received any treatment for my condition yet.There is enough of my tumor to take at least 2 biopsy samples during surgery.I can stay still during MRI scans.I do not have any serious or unstable illnesses.I am scheduled for surgery to remove and biopsy my brain tumor.There isn't enough tissue for two biopsy samples during my surgery.
Research Study Groups:
This trial has the following groups:- Group 1: Baseline Imaging and Biopsy
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.
Can people with the ailment still enroll in the research?
"Yes, the information on clinicaltrials.gov says that this study is actively seeking candidates. The clinical trial was originally posted on 9/20/2022 and was most recently updated on 9/7/2022. The study is looking for 20 patients at 1 locations."
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