drugset / Trial / NCT04114370

Evaluation of 18F-fluciclovine (FACBC) PET/MR Uptake in Participants With Glioma

NCT04114370

Phase 0 Completed 9 enrolled James Mountz Blue Earth Diagnostics · collab
NaSingle-groupOpen-labelOther

Summary

This is a pilot study to assess the ability of \[F-18\]fluciclovine to differentiate pseudoprogression from progression in participants after therapy, at imaging time points within the 12 week interval post chemoradiation. \[F-18\]fluciclovine. PET will be obtained at the time point in the 12 week interval in which MRI demonstrates increase in enhancing volume with the differential diagnosis of pseudoprogression versus tumor progression. At the same time point (at least 6 hours after \[F-18\]fluciclovine or up to 3 days) F-18 FDG will also be performed consistent with standard clinical practice. The verification of pseudoprogression versus tumor progression will be determined by the regression of enhancing lesion on subsequent MRI imaging obtained as part of standard care.

Timeline

Start
2019-10-22
Primary completion
2021-05-18
Completion
2021-09-30

Drugs

EvaluationDrugModalityDoseRoute
Subject 18F-fluciclovine Diagnostic / imaging agent Intravenous

Indications