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Phase II

An Open-label, Single-arm, Single-dose, Prospective, Multicenter Phase 2b Study to Establish Image Interpretation Criteria for 18F-Fluciclovine Positron Emission Tomography (PET) in Detecting Recurrent Brain Metastases After Radiation Therapy

  • Study HIC#:2000028176
  • Last Updated:07/15/2021

An Open-label, Single-arm, Single-dose, Prospective, Multicenter Phase 2b Study to Establish Image Interpretation Criteria for 18F-Fluciclovine Positron Emission Tomography (PET) in Detecting Recurrent Brain Metastases After Radiation Therapy

  • Age18 years and older
  • GenderBoth
  • Start Date09/28/2020
  • End Date07/31/2021

Trial Purpose and Description

Primary Outcome Measures  :

  1. Sensitivity of different thresholds of lesion 18F fluciclovine uptake on visual reads . [ Time Frame: 60 days ]Sensitivity of different thresholds of lesion 18F fluciclovine uptake on visual reads compared to central histopathological analysis.
  2. Specificity of different thresholds of lesion 18F fluciclovine uptake on visual reads. [ Time Frame: 60 days ]Specificity of different thresholds of lesion 18F fluciclovine uptake on visual reads compared to central histopathological analysis.

Eligibility Criteria

Inclusion Criteria:

  1. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
  2. Previous history of solid tumor brain metastasis of any origin
  3. Histopathological confirmation of the primary solid tumor or a metastatic site
  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 craniotomy

Exclusion Criteria:

1. Patients with a history of active hematological malignancy

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