Recruiting

Observational Study

Sponsor:

Indiana University

Code:

NCT05386043

Conditions

Glioma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

FET F-18

O-15 Radioisotope

CT scan

MRI with gadolinium-based contrast

Biopsy Collection

Study Details

Brief summary:

This study is investigating how brain tumors might mutate over time, and whether new brain imaging tools like MRI and PET can predict these mutations.

Conditions

Glioma

Study ID

NCT05386043

Start date

Jul 18, 2023

Status verified date

Sep, 2025

Completion date

Jul 17, 2032

Anticipated

Primary completion date

Jul 17, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.\*\*\*

Study Design

Enrollment

20 participants

Anticipated

Interventions and Outcome Measures

Arms

Baseline Imaging and Biopsy

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.

Interventions

FET F-18

PET scan with FET prior to biopsy

O-15 Radioisotope

PET scan with O-15 Water prior to biopsy

CT scan

CT scan prior to biopsy

MRI with gadolinium-based contrast

MRI prior to biopsy

Biopsy Collection

Biopsy collection during standard of care neurosurgery for glioma diagnosis/excision

Primary outcome measure

  • Classification sensitivity [ Time Frame: Through study completion, an average of 1 year. ]
  • Multivariate analysis [ Time Frame: 2032 ]
  • Survival [ Time Frame: 2032 ]

Central Contacts and Locations

Central contacts

Locations

Indiana University School of Medicine

Recruiting

Indianapolis, Indiana, United States, 46202

Contacts

Principal Investigator:

Jason Parker, PhD

More Information

Sponsor

Indiana University

Last update posted

Sep 15, 2025

Last verified

Sep, 2025

Keywords

  • glioma
  • glioblastoma

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Indiana University on 2025-09-15.