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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 below
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I am between 18 and 89 years old.
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My brain tumor is suspected or confirmed to be Grade II-IV glioma.
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I have not received any treatment for my condition yet.
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There is enough of my tumor to take at least 2 biopsy samples during surgery.
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I can stay still during MRI scans.
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I am scheduled for surgery to remove and biopsy my brain tumor.

ReGIT Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 1 year.
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 1 year. for reporting.

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

Baseline Imaging and Biopsy Clinical Trial Eligibility Overview. Trial Name: NCT05386043 — Phase < 1
Brain Tumor Research Study Groups: Baseline Imaging and Biopsy
Brain Tumor Clinical Trial 2023: Baseline Imaging and Biopsy Highlights & Side Effects. Trial Name: NCT05386043 — Phase < 1
Baseline Imaging and Biopsy 2023 Treatment Timeline for Medical Study. Trial Name: NCT05386043 — Phase < 1

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."

Answered by AI
~12 spots leftby Jul 2025