Clinical trial Recruiting at 1 site Observational Ages 18 and up

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 typeObservational
Ages18 Years and up
SexAll
Enrollment20 (estimated)
SponsorIndiana University
Academic / other
Locations1 site (Indianapolis, Indiana)
StatusRecruiting
StartedJuly 18, 2023
Main results expectedJuly 17, 2030
Study endsJuly 17, 2032
Registry record updatedSeptember 15, 2025
Trial IDNCT05386043 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

  • 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.

  • YN003 injection in glioma patients

    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.

    Recruiting at 2 sites Phase 1 Beijing Inno Medicine Co., Ltd. · Los Angeles, California and 4 other locations · NCT07929909

  • Brain connectome project in adults with brain glioma undergoing surgery

    This registry collects MRI data and clinical information from adults with glioma to see how brain networks relate to surgery and recovery.

    Recruiting Northwell Health · New York, New York · NCT07927595

  • Proton vs. Photon Radiation for Certain Grade 2–3 Gliomas

    This study tests whether proton therapy can better preserve thinking and memory than photon therapy for adults with IDH-mutated grade 2–3 gliomas who need radiation.

    Recruiting at 2 sites University Hospital, Essen · Essen and 1 other locations · NCT07750457

  • Connectome-guided network planning for brain tumor surgery in eloquent areas

    This study tests whether using patient-specific brain network maps from diffusion MRI can help surgeons plan and guide brain tumor removal in eloquent areas.

    Recruiting ARNAS Civico Di Cristina Benfratelli Hospital · Palermo, PA · NCT07717827

  • 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.

    Recruiting Università degli Studi di Trento · Trento · NCT07703761

  • Safusidenib in IDH1-mutant glioma after vorasidenib progression

    This trial tests safusidenib in people with IDH1-mutant glioma who progressed on vorasidenib and did not need immediate chemo or radiation.

    Recruiting at 2 sites Phase 2 Nuvation Bio Inc. · Los Angeles, California and 11 other locations · NCT07703436

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.