Registering Genomics and Imaging of Tumors (ReGIT)

NCT05386043 | Recruiting DMC FDA Drug

• 1 other identifier: 11163
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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

Keywords

glioma; glioblastoma

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (1)

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; Drug: O-15 Radioisotope; Procedure: CT scan; Procedure: MRI with gadolinium-based contrast; Procedure: Biopsy Collection

Interventions

FET F-18 DRUG

PET scan with FET prior to biopsy

Baseline Imaging and Biopsy

O-15 Radioisotope DRUG

PET scan with O-15 Water prior to biopsy

Also known as: O-15 Water

Baseline Imaging and Biopsy

CT scan PROCEDURE

CT scan prior to biopsy

Baseline Imaging and Biopsy

MRI with gadolinium-based contrast PROCEDURE

MRI prior to biopsy

Baseline Imaging and Biopsy

Biopsy Collection PROCEDURE

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

Baseline Imaging and Biopsy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.\*\*\*

Sponsors & Collaborators

• Indiana University: lead
• Children's Hospital of Philadelphia: collaborator

Study Sites (1)

Indiana University School of Medicine

Indianapolis, Indiana, 46202, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Small (\~30mg) tumor tissue samples are removed from the tumor bed and microenvironment using stereotactic core biopsy immediately before performing tumor resection.

MeSH Terms

Conditions

Glioma; Glioblastoma

Interventions

(18F)fluoroethyltyrosine; Oxygen-15; Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Astrocytoma

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Jason Parker, PhD

  Indiana University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jason Parker, PhD

CONTACT

(317) 274-2072; parkerjg@iu.edu

Jason Parker, PhD

CONTACT

317-274-2072; parkerjg@iu.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Department of Radiology and Imaging Sciences

Study Record Dates

• First Submitted: April 26, 2022
• First Posted: May 23, 2022
• Study Start: July 18, 2023
• Primary Completion (Estimated): July 17, 2030
• Study Completion (Estimated): July 17, 2032
• Last Updated: September 15, 2025

Record last verified: 2025-09

Locations

US (1)