Phase 3
N=151
Study to Establish the Diagnostic Performance of 18F Fluciclovine PET in Detecting Recurrent Brain Metastases
Brain Metastases
Bottom Line
View on ClinicalTrials.gov: NCT04410133 ↗Enrolled (actual)
151
Serious AEs
1.3%
Results posted
Aug 2025
Primary outcome: Primary: Positive Percent Agreement (PPA) and Negative Percent Agreement (NPA) Subject Level — 23.8; 34.1; 36.6; 82.6 percentage
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- 18F fluciclovine (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Blue Earth Diagnostics
- Primary completion
- Jun 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Positive Percent Agreement (PPA) and Negative Percent Agreement (NPA) Subject Level |
23.8; 34.1; 36.6; 82.6; 70.9; 70.9 | — |
| SECONDARY Subject Level Positive Predictive Value (PPV) and Negative Predictive Value (NPV) |
34.5; 30.4; 31.9; 73.8; 74.3; 75.0 | — |
| SECONDARY Lesion-level Positive Percent Agreement (PPA) and Negative Percent Agreement (NPA) |
18.4; 28.6; 30.6; 84.1; 74.6; 73.2 | — |
| SECONDARY Lesion-level Positive Predictive Value (PPV) and Negative Predictive Value (NPV) |
29.0; 28.6; 28.8; 74.4; 74.6; 74.8 | — |
| SECONDARY 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 |
50.0; 50.0; 0.0; 83.3; 72.2; 66.7 | — |
| SECONDARY 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 |
25.0; 16.7; 0.0; 93.8; 92.9; 85.7 | — |
| SECONDARY 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 |
0.0; 16.7; 16.7; 100.0; 86.7; 90.0 | — |
| SECONDARY 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 |
20.0; 25.0; 83.3; 83.9; 84.4; 34.5 | — |
| SECONDARY Clinical Usefulness |
26.5 | — |
| SECONDARY Clinical Usefulness |
26.5 | — |
| SECONDARY Clinical Usefulness |
26.5 | — |
| SECONDARY Inter-reader Reproducibility |
86.1; 84.1; 91.4 | — |
| SECONDARY Intra-reader Reproducibility |
93.5; 93.5; 100.0 | — |
| SECONDARY Assess the Safety of Fluciclovine (18F) Injection in the Subject Population, Blood Pressure |
128.7; 132.4; 3.5; 75.4; 77.0; 1.5 | — |
| SECONDARY Assess the Safety of Fluciclovine (18F) Injection in the Subject Population, Heart Rate |
76.2; 74.5; -1.7 | — |
| SECONDARY Assess the Safety of Fluciclovine (18F) Injection in the Subject Population, Respiratory Rate |
16.7; 16.5; -0.2 | — |
| SECONDARY Assess the Safety of Fluciclovine (18F) Injection in the Subject Population, Body Temperature |
36.53; 36.53; -0.00 | — |
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
Eligibility Criteria
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
- Patients with a history of active hematological malignancy
Data sourced from ClinicalTrials.gov (NCT04410133). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.