NCT05386043

Registering Genomics and Imaging of Tumors (ReGIT)

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 20 (estimated)
• Sponsor: Indiana University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Glioma

Interventions

Type	Name	Description
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

Timeline

• Start date: 2023-07-18
• Primary completion: 2030-07-17
• Completion: 2032-07-17
• First posted: 2022-05-23
• Last updated: 2025-09-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study