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Phase III

An Open-label, Single-arm, Single-dose, Prospective, Multicenter Phase 3 Study to Establish the Diagnostic Performance of 18F-Fluciclovine Positron Emission Tomography (PET) in Detecting Recurrent Brain Metastases After Radiation Therapy

  • Study HIC#:2000028546
  • Last Updated:07/15/2021

An open-label, single dose, single arm, prospective, multicenter Phase 3 study to establish the diagnostic performance of 18F fluciclovine positron emission tomography (PET) in detecting recurrent brain metastases after radiation therapy

  • Age18 years and older
  • GenderBoth
  • Start Date11/08/2020
  • End Date03/29/2022

Trial Purpose and Description

Primary Outcome Measures  :

  1. Positive Percent Agreement (PPA) of 18F-fluciclovine PET in detecting recurrent brain metastases [ Time Frame: 6 months ]PPA (equivalent to sensitivity) of 18F-fluciclovine PET in detecting recurrent brain metastases on a subject-level.
  2. Negative Percent Agreement (NPA) of 18F-fluciclovine PET in detecting recurrent brain metastases [ Time Frame: 6 months ]NPA (equivalent to specificity) of 18F-fluciclovine PET in detecting recurrent brain metastases on a subject-level.

Eligibility Criteria

Inclusion Criteria:

  1. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1, or 2 if this is an acute deterioration
  2. Previous history of solid tumor brain metastasis of any origin
  3. Histopathological confirmation of the primary solid tumor or a metastatic site within 4 years
  4. Previous radiation therapy of brain metastatic lesion(s)
  5. A reference lesion considered by the site investigator to be equivocal for recurrent brain metastasis
  6. Patient requires further confirmatory diagnostic procedures to confirm brain MRI findings and is planned for biopsy/neurosurgical intervention as standard of care (SoC) or clinical follow-up as SoC

Exclusion Criteria:

1. Patients with a history of active hematological malignancy

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