NCT05386043 · Indiana University
Registering Genomics and Imaging of Tumors (ReGIT)
(ReGIT)
What this study is about
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.
View original scientific description
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.
Interventions
DRUG
FET F-18
PET scan with FET prior to biopsy
DRUG
O-15 Radioisotope
PET scan with O-15 Water prior to biopsy
PROCEDURE
CT scan
CT scan prior to biopsy
PROCEDURE
MRI with gadolinium-based contrast
MRI prior to biopsy
PROCEDURE
Biopsy Collection
Biopsy collection during standard of care neurosurgery for glioma diagnosis/excision
Primary outcome measures
Classification sensitivity
Time frame: Through study completion, an average of 1 year.
Statistical evaluation of the area under the ROC curve. 3.1.1 SMM classification sensitivity to \>80% 3.1.2 Reduce computation time by a factor of 10, and maintain accuracy (\>.95)
Multivariate analysis
Time frame: 2032
Statistically determine if MRI, and 15O-H2O and FET-PET (if available) independently predict multiscale properties and together improve classification accuracy and sensitivity for SMM compared to 5 baseline MR sequences
Survival
Time frame: 2032
Statistically determine if SMM classifications using MRI, and 15O-H2O and FET-PET (if available) can predict progression-free survival (PFS) and overall survival (OS), and individual voxel responses to chemotherapy and radiation therapy.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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\*.
- Subject is treatment-naïve with the exception of previous biopsy for the above condition.
- Subject is planning to undergo surgical resection and biopsy of their brain tumor.
- Subject has sufficient tissue so that the study team is able to acquire at least 2 biopsy samples during resection.
- Subject is able to read and write in English.
- Subject is able to lay supine for up to 80 minutes.
- Subject is able to hold still during MRI procedures.
- Subject or their LAR has signed the consent form for participation in the study.
Exclusion criteria
- Subject has conditions that would preclude the completion of an MRI such as claustrophobia, pacemaker, metal objects in the body, and/or pregnancy.
- Subject has serious unstable medical or mental illness.
- Subject has insufficient tissue to acquire at least two biopsy samples during resection.
- Subject has a medical contraindication to any element of the study procedures.
- Subject or their LAR has not read and signed the informed consent form, or does not understand its contents.
- Subject is pregnant.\*\
- 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
- Indianapolis, Indiana
Collaborators
Children's Hospital of Philadelphia
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 15, 2025 · Source of record for eligibility and locations