Investigating tumor mutations in glioma patients using advanced imaging techniques
Official title: Registering Genomics and Imaging of Tumors (ReGIT)
Run by Indiana University · NCT05386043 · Data updated 2026-11-12
This study is trying to see if advanced imaging techniques can help predict how brain tumors called gliomas change over time in patients who are having surgery for their tumors.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 20 (estimated) |
| Sponsor | Indiana University Academic / other |
| Locations | 1 site (Indianapolis, Indiana) |
| Status | Recruiting |
| Started | July 18, 2023 |
| Main results expected | July 17, 2030 |
| Study ends | July 17, 2032 |
| Registry record updated | September 15, 2025 |
| Trial ID | NCT05386043 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 to 89 with radiologically diagnosed or suspected WHO Grade II-IV gliomas who are treatment-naïve and planning to undergo surgical resection.
✕Probably not a fit
Patients with conditions that prevent MRI completion, such as claustrophobia or having a pacemaker, may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study focuses on understanding how gliomas, a type of brain tumor, may mutate over time and whether advanced imaging tools like MRI and PET scans can predict these mutations. Participants diagnosed with gliomas who are scheduled for a tumor biopsy will undergo a series of imaging tests and blood draws. The study will collect biopsy samples during surgery to analyze genetic mutations and correlate these findings with imaging results. Follow-up imaging will be conducted as part of the participants' regular care to monitor their condition over time.
Why it matters
Potential benefit: If successful, this study could enhance the ability to predict tumor behavior and improve treatment strategies for glioma patients.
How similar studies have gone: While studies on glioma mutations and imaging have been conducted, this specific approach combining advanced imaging with genetic analysis is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria 1. Subject is between 18 and 89 years of age. 2. 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\*. 3. Subject is treatment-naïve with the exception of previous biopsy for the above condition. 4. Subject is planning to undergo surgical resection and biopsy of their brain tumor. 5. Subject has sufficient tissue so that the study team is able to acquire at least 2 biopsy samples during resection. 6. Subject is able to read and write in English. 7. Subject is able to lay supine for up to 80 minutes. 8. Subject is able to hold still during MRI procedures. 9. Subject or their LAR has signed the consent form for participation in the study. Exclusion Criteria 1. Subject has conditions that would preclude the completion of an MRI such as claustrophobia, pacemaker, metal objects in the body, and/or pregnancy. 2. Subject has serious unstable medical or mental illness. 3. Subject has insufficient tissue to acquire at least two biopsy samples during resection. 4. Subject has a medical contraindication to any element of the study procedures. 5. Subject or their LAR has not read and signed the informed consent form, or does not understand its contents. 6. Subject is pregnant.\*\* 7. Subject is at high risk for NSF (eGFR\<60 or serum creatine \>1.3) and cannot follow the weight-based dosing protocol for Gadavist.\*\*\*
Where it's running
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Indiana University School of Medicine
Indianapolis, Indiana, United States Recruiting
Study contacts
- Principal investigator: Jason Parker, PhD — Indiana University
- Study coordinator: Jason Parker, PhD
- Email: parkerjg@iu.edu
- Phone: (317) 274-2072
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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This phase 1 study tests whether YN003 injected IV is safe and tolerable for adults with recurrent or progressive glioma, and to explore how the drug behaves in the body and any early signs of activity.
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This registry collects MRI data and clinical information from adults with glioma to see how brain networks relate to surgery and recovery.
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Proton vs. Photon Radiation for Certain Grade 2–3 Gliomas
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AI-powered analysis of brain MRI to help glioma care
Doctors will use AI to study existing MRI scans and patient data from adults with glioma to see if it can help with non-invasive diagnosis and treatment planning.
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Safusidenib in IDH1-mutant glioma after vorasidenib progression
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.