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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

Trial Profile

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

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 10 Dec 2018

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At a glance

  • Drugs Fluciclovine 18F (Primary)
  • Indications Glioma
  • Focus Therapeutic Use
  • Most Recent Events

    • 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.
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