Status:
RECRUITING
Registering Genomics and Imaging of Tumors (ReGIT)
Lead Sponsor:
Indiana University
Collaborating Sponsors:
Children's Hospital of Philadelphia
Conditions:
Glioma
Eligibility:
All Genders
18+ years
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.
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 gl...
Eligibility Criteria
Inclusion
- 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.\*\*\*
Exclusion
Key Trial Info
Start Date :
July 18 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
July 17 2032
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT05386043
Start Date
July 18 2023
End Date
July 17 2032
Last Update
September 15 2025
Active Locations (1)
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1
Indiana University School of Medicine
Indianapolis, Indiana, United States, 46202