Registering Genomics and Imaging of Tumors (ReGIT)

• Status: Not yet recruiting
• Trial end date: 2025-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Indiana University
• Collaborator: Children's Hospital of Philadelphia

Criteria

Inclusion Criteria:

1. Subject is between 18 and 89 years of age.

2. Subject has radiologically-diagnosed WHO Grade II-IV glioma.

3. Subject is treatment-naïve 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 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 has signed the consent form for participation in the study.

4.2 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 has not read and signed the informed consent form, or does not understand its contents.

6. Subject is pregnant.*

• Subjects who are female and of childbearing age, are not postmenopausal or status-post sterilization will be tested for pregnancy prior to baseline imaging.