Investigating tumor mutations in glioma patients using advanced imaging techniques

Registering Genomics and Imaging of Tumors (ReGIT)

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
• Enrollment: 20 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Indiana University (Academic / other)
• Locations: 1 site (Indianapolis, Indiana)
• Trial ID: NCT05386043 on ClinicalTrials.gov

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.

Who should consider this trial

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.

Not a fit: Patients with conditions that prevent MRI completion, such as claustrophobia or having a pacemaker, may not benefit from this study.

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 performed: While studies on glioma mutations and imaging have been conducted, this specific approach combining advanced imaging with genetic analysis is relatively novel.

Eligibility 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 this trial is running

Indianapolis, Indiana

• Indiana University School of Medicine — Indianapolis, Indiana, United States (Recruiting)

Study contacts

• Principal investigator: Jason Parker, PhD — Indiana University
• Study coordinator: Jason Parker, PhD

Conditions Glioma; glioma; glioblastoma