RecruitingNCT05386043

Registering Genomics and Imaging of Tumors (ReGIT)

Sponsor

Indiana University

Enrollment

20 participants

Start Date

Jul 18, 2023

Study Type

OBSERVATIONAL

Conditions

Glioma

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria9

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 Criteria7

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.***

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Interventions

DRUGFET F-18

PET scan with FET prior to biopsy

DRUGO-15 Radioisotope

PET scan with O-15 Water prior to biopsy

PROCEDURECT scan

CT scan prior to biopsy

PROCEDUREMRI with gadolinium-based contrast

MRI prior to biopsy

PROCEDUREBiopsy Collection

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

Locations(1)

Indiana University School of Medicine

Indianapolis, Indiana, United States

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NCT05386043

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