Study to Establish the Diagnostic Performance of 18F Fluciclovine PET in Detecting Recurrent Brain Metastases

Study Overview
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Brief Summary
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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

Official Title
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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

Conditions
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Brain Metastases

Intervention / Treatment
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* Drug: 18F fluciclovine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Eastern Cooperative Oncology Group (ECOG) performance status of 0-1, or 2 if this is an acute deterioration Previous history of solid tumor brain metastasis of any origin Histopathological confirmation of the primary solid tumor or a metastatic site within 4 years Previous radiation therapy of brain metastatic lesion(s) A reference lesion considered by the site investigator to be equivocal for recurrent brain metastasis 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Interventional Model Description: Positron Emission Tomography (PET) Imaging study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients<br>Single intravenous administration of 18F fluciclovine for PET Scan | Drug: 18F fluciclovine<br>* 18F fluciclovine injection, 185 MBq (5 mCi) ± 20%, delivered as an intravenous bolus<br>* Other names: Axumin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Positive Percent Agreement (PPA) of 18F-fluciclovine PET in detecting recurrent brain metastases | PPA (equivalent to sensitivity) of 18F-fluciclovine PET in detecting recurrent brain metastases on a subject-level. | 6 months | 
| Negative Percent Agreement (NPA) of 18F-fluciclovine PET in detecting recurrent brain metastases | NPA (equivalent to specificity) of 18F-fluciclovine PET in detecting recurrent brain metastases on a subject-level. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Positive predictive value of 18F-fluciclovine PET in detecting recurrent brain metastases | Positive predictive value of 18F-fluciclovine PET in detecting recurrent brain metastases on a subject-level. | 6 months | 
| Negative predictive value of 18F-fluciclovine PET in detecting recurrent brain metastases | Negative predictive value of 18F-fluciclovine PET in detecting recurrent brain metastases on a subject-level. | 6 months | 
| Treatment-emergent adverse events | Safety will be assessed from data on the occurrence of one or more treatment-emergent Adverse Events from the time of intravenous administration of 18F fluciclovine until 2 days post-18F-fluciclovine administration. | 48 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Recurrent Brain Metastases, Diagnostic, Positron Emission Tomography (PET) Scan