A phase 3 blinded image evaluation (BIE) study of the diagnostic efficacy of 18F-fluciclovine positron emission tomography (PET) imaging, as an adjunct to magnetic resonance imaging (MRI), in adults with glioma
Phase of Trial: Phase III
Latest Information Update: 10 Dec 2018
At a glance
- Drugs Fluciclovine 18F (Primary)
- Indications Glioma
- Focus Therapeutic Use
- 10 Dec 2018 According to a Blue Earth Diagnostics media release, based on the data of this study, the US FDA has accepted for review a supplemental New Drug Application (sNDA) for the expanded use of Axumin (fluciclovine F 18) in adults for the detection and continuing assessment of glioma.
- 05 Dec 2018 New trial record
- 19 Nov 2018 According to a Blue Earth Diagnostics media release, the company plans to publish the full results from this study in an upcoming peer-reviewed medical journal.