Registering Genomics and Imaging of Tumors (ReGIT) (ReGIT)

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.

Study Overview

• Status: Recruiting
• Conditions: Glioma
• Intervention / Treatment: Drug: FET F-18; Drug: O-15 Radioisotope; Procedure: CT scan; Procedure: MRI with gadolinium-based contrast; Procedure: Biopsy Collection

Detailed 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. Subjects who are radiologically diagnosed with gliomas and are expected to undergo a tumor biopsy will be enrolled in the study. Subjects will complete two visits and will then undergo a follow-up period. At the baseline visit, subjects will under go a pregnancy test (if applicable), two PET-CT scans using different radioactive tracers, an MRI scan, and blood draws. At the biopsy visit, the subject will undergo an MRI scan as part of their standard of care and at least biopsy samples will be collected for research purposes using stereotactic core biopsy. The study team will take pictures of the locations of tumor samples as they are removed during surgery. The samples then get studied for genetic mutations, and the study team will look at the parts of the image the samples came from to see if they could have been predicted. Follow-up MRIs and potentially other radiology scans will be completed as part of subjects' regular care on a schedule determined by their healthcare provider at the facility ordered by their physician. The study team will follow subjects' care and collect the information from their regularly scheduled treatments and brain scans after their biopsy.

• Study Type: Observational
• Enrollment (Estimated): 20
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Jason Parker, PhD; Phone Number: (317) 274-2072; Email: parkerjg@iu.edu
• Study Contact Backup: Name: Jason Parker, PhD; Phone Number: 317-274-2072; Email: parkerjg@iu.edu

Study Locations

• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Recruiting
      • Indiana University School of Medicine
      • Contact: Mahsa Servati, MS; Phone Number: 317-278-3384; Email: mservati@iu.edu
      • Principal Investigator: Jason Parker, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Our subject population will consist of a single-arm of human glioma patients (WHO grade II-IV) in an age range of 18-89 years. Patients will be recruited from the IU Health system of academic hospitals including Simon Cancer Center (an NCI-designated Comprehensive Cancer Center), Methodist Hospital, University Hospital, Neuroscience Center, North Hospital, and Saxony Hospital. The total recruitment target for this protocol is up to 20 glioma patients, or approximately 10 patients per year.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Drug: FET F-18; PET scan with FET prior to biopsy; Drug: O-15 Radioisotope; PET scan with O-15 Water prior to biopsy; Other Names: O-15 Water; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Classification sensitivity	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)	Through study completion, an average of 1 year.
Multivariate analysis	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	2032
Survival	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.	2032

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
A list of which scans are necessary for statistically valid routine clinical classification of genomic abnormalities.	This will require statistically determining if 15O-H2O-PET, FET-PET, or MRI sequences independently predict multiscale properties and together improve classification accuracy and sensitivity for SMM compared to 5 baseline MR sequences.	Through study completion, an average of 1 year.
Accuracy of the mathematical algorithms to predict progression-free survival (PFS) and overall survival (OS).		Through study completion, an average of 1 year.

Collaborators and Investigators

• Sponsor: Indiana University
• Collaborators: Children's Hospital of Philadelphia
• Investigators: Principal Investigator: Jason Parker, PhD, Indiana University

Study record dates

Study Major Dates

• Study Start (Actual): July 18, 2023
• Primary Completion (Estimated): July 17, 2030
• Study Completion (Estimated): July 17, 2032

Study Registration Dates

• First Submitted: April 26, 2022
• First Submitted That Met QC Criteria: May 18, 2022
• First Posted (Actual): May 23, 2022

Study Record Updates

• Last Update Posted (Estimated): September 15, 2025
• Last Update Submitted That Met QC Criteria: September 9, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: glioma; glioblastoma
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Astrocytoma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Glioblastoma; Glioma; Investigative Techniques; Chemistry Techniques, Analytical; Spectrum Analysis; Magnetic Resonance Spectroscopy; (18F)fluoroethyltyrosine; Oxygen-15
• Other Study ID Numbers: 11163

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No