NCT05386043 Registering Genomics and Imaging of Tumors (ReGIT)
| NCT ID | NCT05386043 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Indiana University |
| Condition | Glioma |
| Study Type | OBSERVATIONAL |
| Enrollment | 20 participants |
| Start Date | 2023-07-18 |
| Primary Completion | 2030-07-17 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 20 participants in total. It began in 2023-07-18 with a primary completion date of 2030-07-17.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria 1. Subject is between 18 and 89 years of age. 2. 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\*. 3. Subject is treatment-naïve with the exception of previous biopsy 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 biopsy 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 or their LAR has signed the consent form for participation in the study. 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 or their LAR has not read and signed the informed consent form, or does not understand its contents. 6. Subject is pregnant.\*\* 7. Subject is at high risk for NSF (eGFR\<60 or serum creatine \>1.3) and cannot follow the weight-based dosing protocol for Gadavist.\*\*\*
Contact & Investigator
Jason Parker, PhD
PRINCIPAL INVESTIGATOR
Indiana University
Frequently Asked Questions
Who can join the NCT05386043 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Glioma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05386043 currently recruiting?
Yes, NCT05386043 is actively recruiting participants. Contact the research team at parkerjg@iu.edu for enrollment information.
Where is the NCT05386043 trial being conducted?
This trial is being conducted at Indianapolis, United States.
Who is sponsoring the NCT05386043 clinical trial?
NCT05386043 is sponsored by Indiana University. The principal investigator is Jason Parker, PhD at Indiana University. The trial plans to enroll 20 participants.