Brain Metastases
Conditions
Keywords
Recurrent Brain Metastases, Diagnostic, Positron Emission Tomography (PET) Scan
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
Interventions
DRUG18F fluciclovine
18F fluciclovine injection, 185 MBq (5 mCi) ± 20%, delivered as an intravenous bolus
Sponsors
Precision For Medicine
Blue Earth Diagnostics
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
Positron Emission Tomography (PET) Imaging study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. | Number of days taken by the site to establish presence/absence of metastasis by clinical follow-up. |
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Subjects Receiving Single IV Administration of 18F Fluciclovine for PET Scan Subjects with a history of brain metastases previously treated with primary, adjuvant or repeat (salvage) radiation therapy, with a recent (within no more than 42 days before the study PET scan) SoC brain MRI found to be equivocal for recurrent brain metastasis, and who met all the inclusion criteria and none of the exclusion criteria, were consented and enrolled into the study. Specifically, subjects had to be planned for further confirmatory diagnostic procedures to confirm the brain MRI findings: either biopsy/neurosurgical intervention, or clinical follow-up, as SoC. | 151 |
| Total | 151 |
Baseline characteristics
| Characteristic | Subjects Receiving Single IV Administration of 18F Fluciclovine for PET Scan |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 70 Participants |
| Age, Categorical Between 18 and 65 years | 81 Participants |
| Age, Continuous | 61.8 years STANDARD_DEVIATION 11.22 |
| Body mass index (kg/m2) | 27.66 Kg/m2 STANDARD_DEVIATION 6.314 |
| ECOG 0 | 40 Participants |
| ECOG 1 | 96 Participants |
| ECOG 2 | 15 Participants |
| ECOG 3 | 0 Participants |
| ECOG 4 | 0 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 18 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 131 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Height (cm) | 168.25 cm STANDARD_DEVIATION 10.002 |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 5 Participants |
| Race (NIH/OMB) Black or African American | 7 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants |
| Race (NIH/OMB) White | 134 Participants |
| Sex: Female, Male Female | 93 Participants |
| Sex: Female, Male Male | 58 Participants |
| Weight (kg) | 78.72 kg STANDARD_DEVIATION 19.665 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 151 |
| other Total, other adverse events | 15 / 151 |
| serious Total, serious adverse events | 2 / 151 |
Outcome results
Primary
Positive Percent Agreement (PPA) and Negative Percent Agreement (NPA) Subject Level
Subject-level PPA and NPA (equivalent to sensitivity and specificity, respectively) of 18F-fluciclovinePET in detecting recurrent brain metastases.
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Reader 1 - Positive Percent Agreement (PPA) | Positive Percent Agreement (PPA) and Negative Percent Agreement (NPA) Subject Level | 23.8 percentage |
| Reader 2 - Positive Percent Agreement (PPA) | Positive Percent Agreement (PPA) and Negative Percent Agreement (NPA) Subject Level | 34.1 percentage |
| Reader 3 - Positive Percent Agreement (PPA) | Positive Percent Agreement (PPA) and Negative Percent Agreement (NPA) Subject Level | 36.6 percentage |
| Reader 1 - Negative Percent Agreement (NPA) | Positive Percent Agreement (PPA) and Negative Percent Agreement (NPA) Subject Level | 82.6 percentage |
| Reader 2 - Negative Percent Agreement (NPA) | Positive Percent Agreement (PPA) and Negative Percent Agreement (NPA) Subject Level | 70.9 percentage |
| Reader 3 - Negative Percent Agreement (NPA) | Positive Percent Agreement (PPA) and Negative Percent Agreement (NPA) Subject Level | 70.9 percentage |
Secondary
Assess the Safety of Fluciclovine (18F) Injection in the Subject Population, Blood Pressure
Treatment-emergent adverse events (TEAEs) following 18F-fluciclovine injection in the subject population.
Time frame: The vital signs collected between 5 to 60 minutes before and after the PET scan.
Population: Collected and Reported
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Reader 1 - Positive Percent Agreement (PPA) | Assess the Safety of Fluciclovine (18F) Injection in the Subject Population, Blood Pressure | Systolic Blood Pressure: Pre-IMP Injection | 128.7 mmHg | Standard Deviation 17.25 |
| Reader 1 - Positive Percent Agreement (PPA) | Assess the Safety of Fluciclovine (18F) Injection in the Subject Population, Blood Pressure | Systolic Blood Pressure: Post PET Scan | 132.4 mmHg | Standard Deviation 15.25 |
| Reader 1 - Positive Percent Agreement (PPA) | Assess the Safety of Fluciclovine (18F) Injection in the Subject Population, Blood Pressure | Systolic Blood Pressure: Change from Pre to Post | 3.5 mmHg | Standard Deviation 12.81 |
| Reader 1 - Positive Percent Agreement (PPA) | Assess the Safety of Fluciclovine (18F) Injection in the Subject Population, Blood Pressure | Diastolic Blood Pressure: Pre-IMP Injection | 75.4 mmHg | Standard Deviation 10.69 |
| Reader 1 - Positive Percent Agreement (PPA) | Assess the Safety of Fluciclovine (18F) Injection in the Subject Population, Blood Pressure | Diastolic Blood Pressure: Post PET Scan | 77.0 mmHg | Standard Deviation 10.86 |
| Reader 1 - Positive Percent Agreement (PPA) | Assess the Safety of Fluciclovine (18F) Injection in the Subject Population, Blood Pressure | Diastolic Blood Pressure: Change from Pre to Post | 1.5 mmHg | Standard Deviation 7.45 |
Secondary
Assess the Safety of Fluciclovine (18F) Injection in the Subject Population, Body Temperature
Treatment-emergent adverse events (TEAEs) following 18F-fluciclovine injection in the subject population.
Time frame: The vital signs collected between 5 to 60 minutes before and after the PET scan.
Population: Collected and Reported
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Reader 1 - Positive Percent Agreement (PPA) | Assess the Safety of Fluciclovine (18F) Injection in the Subject Population, Body Temperature | Body Temperature: Pre-IMP Injection | 36.53 degrees Celsius | Standard Deviation 0.419 |
| Reader 1 - Positive Percent Agreement (PPA) | Assess the Safety of Fluciclovine (18F) Injection in the Subject Population, Body Temperature | Body Temperature: Post PET Scan | 36.53 degrees Celsius | Standard Deviation 0.455 |
| Reader 1 - Positive Percent Agreement (PPA) | Assess the Safety of Fluciclovine (18F) Injection in the Subject Population, Body Temperature | Body Temperature: Change from Pre to Post | -0.00 degrees Celsius | Standard Deviation 0.29 |
Secondary
Assess the Safety of Fluciclovine (18F) Injection in the Subject Population, Heart Rate
Treatment-emergent adverse events (TEAEs) following 18F-fluciclovine injection in the subject population.
Time frame: The vital signs collected between 5 to 60 minutes before and after the PET scan.
Population: Collected and Reported
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Reader 1 - Positive Percent Agreement (PPA) | Assess the Safety of Fluciclovine (18F) Injection in the Subject Population, Heart Rate | Heart Rate: Pre-IMP Injection | 76.2 beat/min | Standard Deviation 13.53 |
| Reader 1 - Positive Percent Agreement (PPA) | Assess the Safety of Fluciclovine (18F) Injection in the Subject Population, Heart Rate | Heart Rate: Post PET Scan | 74.5 beat/min | Standard Deviation 12.93 |
| Reader 1 - Positive Percent Agreement (PPA) | Assess the Safety of Fluciclovine (18F) Injection in the Subject Population, Heart Rate | Heart Rate: Change from Pre to Post | -1.7 beat/min | Standard Deviation 8.43 |
Secondary
Assess the Safety of Fluciclovine (18F) Injection in the Subject Population, Respiratory Rate
Treatment-emergent adverse events (TEAEs) following 18F-fluciclovine injection in the subject population.
Time frame: The vital signs collected between 5 to 60 minutes before and after the PET scan.
Population: Collected and Reported
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Reader 1 - Positive Percent Agreement (PPA) | Assess the Safety of Fluciclovine (18F) Injection in the Subject Population, Respiratory Rate | Respiratory Rate: Pre-IMP Injection | 16.7 breaths/min | Standard Deviation 2.76 |
| Reader 1 - Positive Percent Agreement (PPA) | Assess the Safety of Fluciclovine (18F) Injection in the Subject Population, Respiratory Rate | Respiratory Rate: Post PET Scan | 16.5 breaths/min | Standard Deviation 2.72 |
| Reader 1 - Positive Percent Agreement (PPA) | Assess the Safety of Fluciclovine (18F) Injection in the Subject Population, Respiratory Rate | Respiratory Rate: Change from Pre to Post | -0.2 breaths/min | Standard Deviation 1.85 |
Secondary
Clinical Usefulness
Proportion of subjects with additional metastases identified on fluciclovine (18F) PET in addition to SoC brain MRI
Time frame: Follow up through 6 months after PET scan.
Population: Subjects with Additional Metastases Identified on Fluciclovine (18F) PET vs SoC MRI
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Reader 1 - Positive Percent Agreement (PPA) | Clinical Usefulness | 1.3 percentage |
Secondary
Clinical Usefulness
Number of days taken by the site to establish presence/absence of metastasis by clinical follow-up.
Time frame: Follow up through 6 months after PET scan.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Reader 1 - Positive Percent Agreement (PPA) | Clinical Usefulness | 112 Days |
Secondary
Clinical Usefulness
Proportion of subjects whose prospective diagnostic management plan changed following fluciclovine (18F) PET.
Time frame: Follow up through 6 months after PET scan.
Population: Subjects with Changes to Diagnostic Plan on Reference Lesion Following Fluciclovine (18F) PET
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Reader 1 - Positive Percent Agreement (PPA) | Clinical Usefulness | 26.5 percentage |
Secondary
Inter-reader Reproducibility
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.
Time frame: PET Scan Day 1
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Reader 1 - Positive Percent Agreement (PPA) | Inter-reader Reproducibility | Reader 1 vs Reader 2 | 86.1 percentage |
| Reader 1 - Positive Percent Agreement (PPA) | Inter-reader Reproducibility | Reader 1 vs Reader 3 | 84.1 percentage |
| Reader 1 - Positive Percent Agreement (PPA) | Inter-reader Reproducibility | Reader 2 vs Reader 3 | 91.4 percentage |
Secondary
Intra-reader Reproducibility
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.
Time frame: PET Scan Day 1
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Reader 1 - Positive Percent Agreement (PPA) | Intra-reader Reproducibility | Reader 1 initial read vs re-read | 93.5 percentage |
| Reader 1 - Positive Percent Agreement (PPA) | Intra-reader Reproducibility | Reader 2 initial read vs re-read | 93.5 percentage |
| Reader 1 - Positive Percent Agreement (PPA) | Intra-reader Reproducibility | Reader 3 initial read vs re-read | 100.0 percentage |
Secondary
Lesion-level Positive Percent Agreement (PPA) and Negative Percent Agreement (NPA)
To assess lesion-level PPA & NPA diagnostic performance of 18F-fluciclovine PET in detecting recurrent brain metastases.
Time frame: 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.
Population: Each participant may have more than one lesion (one reference lesion, and/or other equivocal lesions and/or additional PET lesions if applicable). At the participant level, if the reference lesion is indeterminate, then the worst case is used to impute the indeterminate finding into positive or negative. However, at the lesion level, lesions with indeterminate findings are excluded i.e. only lesions with positive or negative finding are included in the analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Reader 1 - Positive Percent Agreement (PPA) | Lesion-level Positive Percent Agreement (PPA) and Negative Percent Agreement (NPA) | 18.4 percentage |
| Reader 2 - Positive Percent Agreement (PPA) | Lesion-level Positive Percent Agreement (PPA) and Negative Percent Agreement (NPA) | 28.6 percentage |
| Reader 3 - Positive Percent Agreement (PPA) | Lesion-level Positive Percent Agreement (PPA) and Negative Percent Agreement (NPA) | 30.6 percentage |
| Reader 1 - Negative Percent Agreement (NPA) | Lesion-level Positive Percent Agreement (PPA) and Negative Percent Agreement (NPA) | 84.1 percentage |
| Reader 2 - Negative Percent Agreement (NPA) | Lesion-level Positive Percent Agreement (PPA) and Negative Percent Agreement (NPA) | 74.6 percentage |
| Reader 3 - Negative Percent Agreement (NPA) | Lesion-level Positive Percent Agreement (PPA) and Negative Percent Agreement (NPA) | 73.2 percentage |
Secondary
Lesion-level Positive Predictive Value (PPV) and Negative Predictive Value (NPV)
To assess lesion-level PPV & NPV diagnostic performance of 18F-fluciclovine PET in detecting recurrent brain metastases.
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Reader 1 - Positive Percent Agreement (PPA) | Lesion-level Positive Predictive Value (PPV) and Negative Predictive Value (NPV) | 29.0 percentage |
| Reader 2 - Positive Percent Agreement (PPA) | Lesion-level Positive Predictive Value (PPV) and Negative Predictive Value (NPV) | 28.6 percentage |
| Reader 3 - Positive Percent Agreement (PPA) | Lesion-level Positive Predictive Value (PPV) and Negative Predictive Value (NPV) | 28.8 percentage |
| Reader 1 - Negative Percent Agreement (NPA) | Lesion-level Positive Predictive Value (PPV) and Negative Predictive Value (NPV) | 74.4 percentage |
| Reader 2 - Negative Percent Agreement (NPA) | Lesion-level Positive Predictive Value (PPV) and Negative Predictive Value (NPV) | 74.6 percentage |
| Reader 3 - Negative Percent Agreement (NPA) | Lesion-level Positive Predictive Value (PPV) and Negative Predictive Value (NPV) | 74.8 percentage |
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
Sub-group analyses of subject-level PPA & NPA of fluciclovine (18F) PET, according to concurrent immunotherapy.
Time frame: 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.
Population: All subjects with a positive or negative Standard of Reference (SoR), with outcome measures categorized by concurrent Immunotherapy.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Reader 1 - Positive Percent Agreement (PPA) | 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 | Received Concurrent Immunotherapy | 0.0 percentage |
| Reader 1 - Positive Percent Agreement (PPA) | 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 | Did Not Receive Concurrent Immunotherapy | 27.8 percentage |
| Reader 2 - Positive Percent Agreement (PPA) | 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 | Received Concurrent Immunotherapy | 16.7 percentage |
| Reader 2 - Positive Percent Agreement (PPA) | 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 | Did Not Receive Concurrent Immunotherapy | 37.1 percentage |
| Reader 3 - Positive Percent Agreement (PPA) | 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 | Received Concurrent Immunotherapy | 16.7 percentage |
| Reader 3 - Positive Percent Agreement (PPA) | 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 | Did Not Receive Concurrent Immunotherapy | 40.0 percentage |
| Reader 1 - Negative Percent Agreement (NPA) | 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 | Received Concurrent Immunotherapy | 100.0 percentage |
| Reader 1 - Negative Percent Agreement (NPA) | 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 | Did Not Receive Concurrent Immunotherapy | 75.9 percentage |
| Reader 2 - Negative Percent Agreement (NPA) | 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 | Received Concurrent Immunotherapy | 86.7 percentage |
| Reader 2 - Negative Percent Agreement (NPA) | 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 | Did Not Receive Concurrent Immunotherapy | 65.0 percentage |
| Reader 3 - Negative Percent Agreement (NPA) | 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 | Received Concurrent Immunotherapy | 90.0 percentage |
| Reader 3 - Negative Percent Agreement (NPA) | 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 | Did Not Receive Concurrent Immunotherapy | 63.8 percentage |
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
Sub-group analyses of subject-level PPA & NPA of fluciclovine (18F) PET, according to primary tumor type.
Time frame: 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.
Population: All subjects with a positive or negative Standard of Reference (SoR), with outcome measures categorized by tumor type.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Reader 1 - Positive Percent Agreement (PPA) | 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 | Non Lung/Breast/Melanoma | 16.7 percentage |
| Reader 1 - Positive Percent Agreement (PPA) | 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 | Melanoma | 50.0 percentage |
| Reader 1 - Positive Percent Agreement (PPA) | 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 | Lung Cancer | 29.2 percentage |
| Reader 1 - Positive Percent Agreement (PPA) | 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 | Breast | 10.0 percentage |
| Reader 2 - Positive Percent Agreement (PPA) | 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 | Breast | 30.0 percentage |
| Reader 2 - Positive Percent Agreement (PPA) | 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 | Non Lung/Breast/Melanoma | 16.7 percentage |
| Reader 2 - Positive Percent Agreement (PPA) | 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 | Melanoma | 50.0 percentage |
| Reader 2 - Positive Percent Agreement (PPA) | 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 | Lung Cancer | 39.1 percentage |
| Reader 3 - Positive Percent Agreement (PPA) | 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 | Melanoma | 0.0 percentage |
| Reader 3 - Positive Percent Agreement (PPA) | 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 | Breast | 40.0 percentage |
| Reader 3 - Positive Percent Agreement (PPA) | 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 | Lung Cancer | 43.5 percentage |
| Reader 3 - Positive Percent Agreement (PPA) | 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 | Non Lung/Breast/Melanoma | 16.7 percentage |
| Reader 1 - Negative Percent Agreement (NPA) | 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 | Melanoma | 83.3 percentage |
| Reader 1 - Negative Percent Agreement (NPA) | 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 | Lung Cancer | 85.4 percentage |
| Reader 1 - Negative Percent Agreement (NPA) | 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 | Breast | 78.3 percentage |
| Reader 1 - Negative Percent Agreement (NPA) | 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 | Non Lung/Breast/Melanoma | 80.0 percentage |
| Reader 2 - Negative Percent Agreement (NPA) | 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 | Non Lung/Breast/Melanoma | 80.0 percentage |
| Reader 2 - Negative Percent Agreement (NPA) | 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 | Lung Cancer | 69.4 percentage |
| Reader 2 - Negative Percent Agreement (NPA) | 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 | Melanoma | 72.2 percentage |
| Reader 2 - Negative Percent Agreement (NPA) | 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 | Breast | 65.2 percentage |
| Reader 3 - Negative Percent Agreement (NPA) | 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 | Lung Cancer | 67.3 percentage |
| Reader 3 - Negative Percent Agreement (NPA) | 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 | Breast | 73.9 percentage |
| Reader 3 - Negative Percent Agreement (NPA) | 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 | Melanoma | 66.7 percentage |
| Reader 3 - Negative Percent Agreement (NPA) | 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 | Non Lung/Breast/Melanoma | 80.0 percentage |
Secondary
Subject Level Positive Predictive Value (PPV) and Negative Predictive Value (NPV)
Subject-level PPV and NPV of 18F-fluciclovine PET for detecting recurrent brain metastases
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Reader 1 - Positive Percent Agreement (PPA) | Subject Level Positive Predictive Value (PPV) and Negative Predictive Value (NPV) | 34.5 percentage |
| Reader 2 - Positive Percent Agreement (PPA) | Subject Level Positive Predictive Value (PPV) and Negative Predictive Value (NPV) | 30.4 percentage |
| Reader 3 - Positive Percent Agreement (PPA) | Subject Level Positive Predictive Value (PPV) and Negative Predictive Value (NPV) | 31.9 percentage |
| Reader 1 - Negative Percent Agreement (NPA) | Subject Level Positive Predictive Value (PPV) and Negative Predictive Value (NPV) | 73.8 percentage |
| Reader 2 - Negative Percent Agreement (NPA) | Subject Level Positive Predictive Value (PPV) and Negative Predictive Value (NPV) | 74.3 percentage |
| Reader 3 - Negative Percent Agreement (NPA) | Subject Level Positive Predictive Value (PPV) and Negative Predictive Value (NPV) | 75.0 percentage |
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
Sub-group analyses of subject-level PPV & NPV of fluciclovine (18F) PET, according to Concurrent Immunotherapy.
Time frame: 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.
Population: All subjects with a positive or negative finding by BIE, with outcome measures categorized by concurrent Immunotherapy.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Reader 1 - Positive Percent Agreement (PPA) | 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 | Did Not Receive Concurrent Immunotherapy | 34.5 percentage |
| Reader 2 - Positive Percent Agreement (PPA) | 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 | Received Concurrent Immunotherapy | 20.0 percentage |
| Reader 2 - Positive Percent Agreement (PPA) | 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 | Did Not Receive Concurrent Immunotherapy | 31.7 percentage |
| Reader 3 - Positive Percent Agreement (PPA) | 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 | Received Concurrent Immunotherapy | 25.0 percentage |
| Reader 3 - Positive Percent Agreement (PPA) | 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 | Did Not Receive Concurrent Immunotherapy | 32.6 percentage |
| Reader 1 - Negative Percent Agreement (NPA) | 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 | Received Concurrent Immunotherapy | 83.3 percentage |
| Reader 1 - Negative Percent Agreement (NPA) | 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 | Did Not Receive Concurrent Immunotherapy | 69.8 percentage |
| Reader 2 - Negative Percent Agreement (NPA) | 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 | Received Concurrent Immunotherapy | 83.9 percentage |
| Reader 2 - Negative Percent Agreement (NPA) | 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 | Did Not Receive Concurrent Immunotherapy | 70.3 percentage |
| Reader 3 - Negative Percent Agreement (NPA) | 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 | Received Concurrent Immunotherapy | 84.4 percentage |
| Reader 3 - Negative Percent Agreement (NPA) | 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 | Did Not Receive Concurrent Immunotherapy | 70.8 percentage |
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
Sub-group analyses of subject-level PPV & NPV of fluciclovine (18F) PET, according to primary tumor type.
Time frame: 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.
Population: All subjects with a positive or negative finding by BIE, with outcome measures categorized by tumor type.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Reader 1 - Positive Percent Agreement (PPA) | 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 | Melanoma | 25.0 percentage |
| Reader 1 - Positive Percent Agreement (PPA) | 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 | Lung Cancer | 50.0 percentage |
| Reader 1 - Positive Percent Agreement (PPA) | 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 | Breast | 16.7 percentage |
| Reader 1 - Positive Percent Agreement (PPA) | 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 | Non Lung/Breast/Melanoma | 20.0 percentage |
| Reader 2 - Positive Percent Agreement (PPA) | 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 | Melanoma | 16.7 percentage |
| Reader 2 - Positive Percent Agreement (PPA) | 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 | Breast | 27.3 percentage |
| Reader 2 - Positive Percent Agreement (PPA) | 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 | Non Lung/Breast/Melanoma | 20.0 percentage |
| Reader 2 - Positive Percent Agreement (PPA) | 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 | Lung Cancer | 37.5 percentage |
| Reader 3 - Positive Percent Agreement (PPA) | 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 | Non Lung/Breast/Melanoma | 20.0 percentage |
| Reader 3 - Positive Percent Agreement (PPA) | 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 | Lung Cancer | 38.5 percentage |
| Reader 3 - Positive Percent Agreement (PPA) | 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 | Breast | 40.0 percentage |
| Reader 3 - Positive Percent Agreement (PPA) | 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 | Melanoma | 0.0 percentage |
| Reader 1 - Negative Percent Agreement (NPA) | 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 | Breast | 66.7 percentage |
| Reader 1 - Negative Percent Agreement (NPA) | 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 | Lung Cancer | 70.7 percentage |
| Reader 1 - Negative Percent Agreement (NPA) | 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 | Non Lung/Breast/Melanoma | 76.2 percentage |
| Reader 1 - Negative Percent Agreement (NPA) | 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 | Melanoma | 93.8 percentage |
| Reader 2 - Negative Percent Agreement (NPA) | 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 | Melanoma | 92.9 percentage |
| Reader 2 - Negative Percent Agreement (NPA) | 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 | Non Lung/Breast/Melanoma | 76.2 percentage |
| Reader 2 - Negative Percent Agreement (NPA) | 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 | Lung Cancer | 70.8 percentage |
| Reader 2 - Negative Percent Agreement (NPA) | 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 | Breast | 68.2 percentage |
| Reader 3 - Negative Percent Agreement (NPA) | 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 | Breast | 73.9 percentage |
| Reader 3 - Negative Percent Agreement (NPA) | 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 | Melanoma | 85.7 percentage |
| Reader 3 - Negative Percent Agreement (NPA) | 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 | Lung Cancer | 71.7 percentage |
| Reader 3 - Negative Percent Agreement (NPA) | 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 | Non Lung/Breast/Melanoma | 76.2 percentage |