Evaluation of 18F-fluciclovine (FACBC) PET/MR Uptake in Participants With Glioma (FACBC)
Glioma
About this trial
This is an interventional other trial for Glioma
Eligibility Criteria
Inclusion Criteria:
1. Age ≥ 18 years old.
2. Been previously diagnosed by resection or biopsy with grade 3 or 4 glioma.
3. Agree to use adequate contraception as indicated in this protocol.
4. Consent to PET scanning and receipt of one injection of 18F-fluciclovine.
5. Able to comply with study procedures.
6. Able to give written consent.
7. Subject has had a standard of care, diagnostic MRI study which was indeterminate due to the inability to differentiate pseudoprogression versus tumor progression.
Exclusion Criteria:
1. Are a pregnant or breastfeeding female.
2. Are participating in a clinical trial of another unlicensed product.
3. Are undergoing 18F-fluciclovine PET for reason(s) other than newly diagnosed or recurrent glioma.
4. Have a hypersensitivity to 18F-fluciclovine.
5. Have acute renal failure or moderate/severe renal impairment, according to local clinical guidelines.
6. Have a non-MRI compatible implantable device or another contraindication for MRI scan.
7. Are deemed ineligible to participate for other reasons by an investigator.
Sites / Locations
- UPMC Hospitals
Arms of the Study
Arm 1
Experimental
Participants with Glioma
[F18]fluciclovine will be utilized to assess tumor viability compared with F-18 FDG PET or diagnostic MRI.