drugset / Trial / NCT03276676

[18F]Fluciclovine and [18F]FLT PET/CT Assessment of Primary High-Grade Brain Tumors

NCT03276676

Phase 1/2 Terminated 10 enrolled University of Utah Blue Earth Diagnostics · collab
Non-randomizedSingle-groupOpen-labelDiagnostic

Summary

The hypothesis of this exploratory clinical trial in patients with high-grade a primary brain tumor who receive chemoradiation is that the PET imaging agents \[18F\]Fluciclovine and/or \[18F\]FLT will be a better predictor of tumor response than standard MRI based brain tumor response criteria. When used in conjunction, the two PET agents may be better able to predict tumor aggressiveness and thus overall survival than the use of individual-tracer PET biomarkers. This may eventually lead to improved assessment of response (including time to progression and overall survival) and differentiation of tumor recurrence/progression from treatment effect (pseudoprogression).

Timeline

Start
2018-09-24
Primary completion
2021-04-12
Completion
2023-08-18

Drugs

EvaluationDrugModalityDoseRoute
Subject 18F-FLT Diagnostic / imaging agent
Subject 18F-fluciclovine Diagnostic / imaging agent

Indications