Study to Establish the Diagnostic Performance of 18F Fluciclovine PET in Detecting Recurrent Brain Metastases
- Registration Number
- NCT04410133
- Lead Sponsor
- Blue Earth Diagnostics
- Brief Summary
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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 151
- 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
1. Patients with a history of active hematological malignancy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Patients 18F fluciclovine Single intravenous administration of 18F fluciclovine for PET Scan
- Primary Outcome Measures
Name Time Method Positive Percent Agreement (PPA) and Negative Percent Agreement (NPA) Subject Level MRI for anatomical correlation within 3 days of IMP and PET scan, followed by surgical intervention (if applicable) post-PET scan and follow up through 6 months after PET scan. Subject-level PPA and NPA (equivalent to sensitivity and specificity, respectively) of 18F-fluciclovinePET in detecting recurrent brain metastases.
- Secondary Outcome Measures
Name Time Method Subject Level Positive Predictive Value (PPV) and Negative Predictive Value (NPV) MRI for anatomical correlation within 3 days of IMP and PET scan, followed by surgical intervention (if applicable) post-PET scan and follow up through 6 months after PET scan. Subject-level PPV and NPV of 18F-fluciclovine PET for detecting recurrent brain metastases
Lesion-level Positive Percent Agreement (PPA) and Negative Percent Agreement (NPA) MRI for anatomical correlation within 3 days of IMP and PET scan, followed by surgical intervention (if applicable) post-PET scan and follow up through 6 months after PET scan. To assess lesion-level PPA \& NPA diagnostic performance of 18F-fluciclovine PET in detecting recurrent brain metastases.
Lesion-level Positive Predictive Value (PPV) and Negative Predictive Value (NPV) MRI for anatomical correlation within 3 days of IMP and PET scan, followed by surgical intervention (if applicable) post-PET scan and follow up through 6 months after PET scan. To assess lesion-level PPV \& NPV diagnostic performance of 18F-fluciclovine PET in detecting recurrent brain metastases.
Subject-level Positive Percent Agreement (PPA) & Negative Percent Agreement (NPA) Diagnostic Performance of Fluciclovine (18F) PET in Detecting Recurrent Brain Metastases in Different Clinical Settings - Tumor Type MRI for anatomical correlation within 3 days of IMP and PET scan, followed by surgical intervention (if applicable) post-PET scan and follow up through 6 months after PET scan. Sub-group analyses of subject-level PPA \& NPA of fluciclovine (18F) PET, according to primary tumor type.
Subject-level Positive Predictive Value (PPV) & Negative Predictive Value (NPV) Diagnostic Performance of Fluciclovine (18F) PET in Detecting Recurrent Brain Metastases in Different Clinical Settings - Tumor Type MRI for anatomical correlation within 3 days of IMP and PET scan, followed by surgical intervention (if applicable) post-PET scan and follow up through 6 months after PET scan. Sub-group analyses of subject-level PPV \& NPV of fluciclovine (18F) PET, according to primary tumor type.
Subject-level Positive Percent Agreement (NPA) & Negative Percent Agreement (NPA) Diagnostic Performance of Fluciclovine (18F) PET in Detecting Recurrent Brain Metastases in Different Clinical Settings - Concurrent Immunotherapy MRI for anatomical correlation within 3 days of IMP and PET scan, followed by surgical intervention (if applicable) post-PET scan and follow up through 6 months after PET scan. Sub-group analyses of subject-level PPA \& NPA of fluciclovine (18F) PET, according to concurrent immunotherapy.
Subject-level Positive Predictive Value (PPV) & Negative Predictive Value (NPV) Diagnostic Performance of Fluciclovine (18F) PET in Detecting Recurrent Brain Metastases in Different Clinical Settings - Concurrent Immunotherapy MRI for anatomical correlation within 3 days of IMP and PET scan, followed by surgical intervention (if applicable) post-PET scan and follow up through 6 months after PET scan. Sub-group analyses of subject-level PPV \& NPV of fluciclovine (18F) PET, according to Concurrent Immunotherapy.
Clinical Usefulness Follow up through 6 months after PET scan. Proportion of subjects whose prospective diagnostic management plan changed following fluciclovine (18F) PET.
Inter-reader Reproducibility PET Scan Day 1 Pairwise comparisons of the central reads for the 3 readers (i.e. Reader 1 vs Reader 2, Reader 1 vs Reader 3, and Reader 2 vs Reader 3) at the subject-level. The percentage of results in agreement (i.e. Positive \[1st reader\] / Positive \[2nd reader\], Negative/Negative) is presented.
Intra-reader Reproducibility PET Scan Day 1 Pairwise comparisons of the initial read vs re-read of a subset of PET scans for each reader at the subject-level. The percentage of results in agreement (i.e. Positive \[initial read\] / Positive \[re-read\], Negative/Negative) is presented.
Assess the Safety of Fluciclovine (18F) Injection in the Subject Population, Blood Pressure The vital signs collected between 5 to 60 minutes before and after the PET scan. Treatment-emergent adverse events (TEAEs) following 18F-fluciclovine injection in the subject population.
Assess the Safety of Fluciclovine (18F) Injection in the Subject Population, Heart Rate The vital signs collected between 5 to 60 minutes before and after the PET scan. Treatment-emergent adverse events (TEAEs) following 18F-fluciclovine injection in the subject population.
Assess the Safety of Fluciclovine (18F) Injection in the Subject Population, Respiratory Rate The vital signs collected between 5 to 60 minutes before and after the PET scan. Treatment-emergent adverse events (TEAEs) following 18F-fluciclovine injection in the subject population.
Assess the Safety of Fluciclovine (18F) Injection in the Subject Population, Body Temperature The vital signs collected between 5 to 60 minutes before and after the PET scan. Treatment-emergent adverse events (TEAEs) following 18F-fluciclovine injection in the subject population.
Trial Locations
- Locations (19)
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
St. Joseph's Hospital and Medical Center
🇺🇸Phoenix, Arizona, United States
University of California, San Francisco
🇺🇸San Francisco, California, United States
John Wayne Cancer Institute at Providence St. John's Health Center
🇺🇸Santa Monica, California, United States
Yale School of Medicine
🇺🇸New Haven, Connecticut, United States
Miami Cancer Institute at Baptist Health, Inc.
🇺🇸Miami, Florida, United States
Medical College of Georgia, Augusta University
🇺🇸Augusta, Georgia, United States
Ochsner Clinic Foundation
🇺🇸New Orleans, Louisiana, United States
Johns Hopkins Hospital
🇺🇸Baltimore, Maryland, United States
University of Michigan Rogel Cancer Center
🇺🇸Ann Arbor, Michigan, United States
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