| 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. | | Posted | | Number | 95% Confidence Interval | percentage | | 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. | | | | ID | Title | Description |
|---|
| OG000 | Reader 1 - Positive Percent Agreement (PPA) | Only subjects with a positive standard of reference are included in the denominator for each reader. | | OG001 | Reader 2 - Positive Percent Agreement (PPA) | Only subjects with a positive standard of reference are included in the denominator for each reader. | | OG002 | Reader 3 - Positive Percent Agreement (PPA) | Only subjects with a positive standard of reference are included in the denominator for each reader. | | OG003 | Reader 1 - Negative Percent Agreement (NPA) | Only subjects with a negative standard of reference are included in the denominator for each reader. | | OG004 | Reader 2 - Negative Percent Agreement (NPA) | Only subjects with a negative standard of reference are included in the denominator for each reader. | | OG005 | Reader 3 - Negative Percent Agreement (NPA) | Only subjects with a negative standard of reference are included in the denominator for each reader. |
| | Units | Counts |
|---|
| Participants | - OG00042
- OG00141
- OG00241
- OG003
|
| | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG00023.8(12.1 to 39.5)
- OG00134.1(20.1 to 50.6)
- OG00236.6(22.1 to 53.1)
- OG003
|
|
| |
| 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 | | Posted | | Number | 95% Confidence Interval | percentage | | 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. | | | | ID | Title | Description |
|---|
| OG000 | Reader 1 - Positive Predictive Value (PPV) | Only subjects with a positive finding by BIE are included in the denominator for each reader. | | OG001 | Reader 2 - Positive Predictive Value (PPV) | Only subjects with a positive finding by BIE are included in the denominator for each reader. | | OG002 | Reader 3 - Positive Predictive Value (PPV) | Only subjects with a positive finding by BIE are included in the denominator for each reader. | | OG003 | Reader 1 - Negative Predictive Value (NPV) | Only subjects with a negative finding by BIE are included in the denominator for each reader. |
|
| 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. | 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. | Posted | | Number | 95% Confidence Interval | percentage | | 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. | Lesions | Lesions | | ID | Title | Description |
|---|
| OG000 | Reader 1 - Positive Percent Agreement (PPA) | Only Lesions with a positive standard of reference are included in the denominator for each reader. | | OG001 | Reader 2 - Positive Percent Agreement (PPA) | Only Lesions with a positive standard of reference are included in the denominator for each reader. | | OG002 | Reader 3 - Positive Percent Agreement (PPA) |
|
| 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. | | Posted | | Number | 95% Confidence Interval | percentage | | 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. | Lesions | Lesions | | ID | Title | Description |
|---|
| OG000 | Reader 1 - Positive Predictive Value (PPV) | Only Lesions with a positive finding by BIE are included in the denominator for reach reader | | OG001 | Reader 2 - Positive Predictive Value (PPV) | Only Lesions with a positive finding by BIE are included in the denominator for reach reader | | OG002 | Reader 3 - Positive Predictive Value (PPV) | Only Lesions with a positive finding by BIE are included in the denominator for reach reader | | OG003 | Reader 1 - Negative Predictive Value (NPV) | Only Lesions with a negative finding by BIE are included in the denominator for reach reader |
|
| 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. | All subjects with a positive or negative Standard of Reference (SoR), with outcome measures categorized by tumor type. | Posted | | Number | 95% Confidence Interval | percentage | | 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. | | | | ID | Title | Description |
|---|
| OG000 | Reader 1 - Positive Percent Agreement (NPA) | Only subjects with a positive standard of reference are included in the denominator for each reader. | | OG001 | Reader 2 - Positive Percent Agreement (NPA) | Only subjects with a positive standard of reference are included in the denominator for each reader. | | OG002 | Reader 3 - Positive Percent Agreement (NPA) | Only subjects with a positive standard of reference are included in the denominator for each reader. |
|
| 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. | All subjects with a positive or negative finding by BIE, with outcome measures categorized by tumor type. | Posted | | Number | 95% Confidence Interval | percentage | | 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. | | | | ID | Title | Description |
|---|
| OG000 | Reader 1 - Positive Predictive Value (PPV) | Only subjects with a positive finding by BIE are included in the denominator for reach reader | | OG001 | Reader 2 - Positive Predictive Value (PPV) | Only subjects with a positive finding by BIE are included in the denominator for reach reader | | OG002 | Reader 3 - Positive Predictive Value (PPV) | Only subjects with a positive finding by BIE are included in the denominator for reach reader | |
|
| 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. | All subjects with a positive or negative Standard of Reference (SoR), with outcome measures categorized by concurrent Immunotherapy. | Posted | | Number | 95% Confidence Interval | percentage | | 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. | | | | ID | Title | Description |
|---|
| OG000 | Reader 1 - Positive Percent Agreement (NPA) | Only subjects with a positive standard of reference are included in the denominator for each reader. | | OG001 | Reader 2 - Positive Percent Agreement (NPA) | Only subjects with a positive standard of reference are included in the denominator for each reader. | | OG002 | Reader 3 - Positive Percent Agreement (NPA) | Only subjects with a positive standard of reference are included in the denominator for each reader. |
|
| 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. | All subjects with a positive or negative finding by BIE, with outcome measures categorized by concurrent Immunotherapy. | Posted | | Number | 95% Confidence Interval | percentage | | 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. | | | | ID | Title | Description |
|---|
| OG000 | Reader 1 - Positive Predictive Value (PPV) | Only subjects with a positive finding by BIE are included in the denominator for reach reader | | OG001 | Reader 2 - Positive Predictive Value (PPV) | Only subjects with a positive finding by BIE are included in the denominator for reach reader | | OG002 | Reader 3 - Positive Predictive Value (PPV) | Only subjects with a positive finding by BIE are included in the denominator for reach reader |
|
| Secondary | Clinical Usefulness | Number of days taken by the site to establish presence/absence of metastasis by clinical follow-up. | | Posted | | Median | 95% Confidence Interval | Days | | Follow up through 6 months after PET scan. | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| Secondary | Clinical Usefulness | Proportion of subjects with additional metastases identified on fluciclovine (18F) PET in addition to SoC brain MRI | Subjects with Additional Metastases Identified on Fluciclovine (18F) PET vs SoC MRI | Posted | | Number | 95% Confidence Interval | percentage | | Follow up through 6 months after PET scan. | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| Secondary | Clinical Usefulness | Proportion of subjects whose prospective diagnostic management plan changed following fluciclovine (18F) PET. | Subjects with Changes to Diagnostic Plan on Reference Lesion Following Fluciclovine (18F) PET | Posted | | Number | 95% Confidence Interval | percentage | | Follow up through 6 months after PET scan. | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| 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. | | Posted | | Number | | percentage | | PET Scan Day 1 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| 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. | | Posted | | Number | | percentage | | PET Scan Day 1 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| 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. | | Posted | | Mean | Standard Deviation | mmHg | | The vital signs collected between 5 to 60 minutes before and after the PET scan. | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| 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. | | Posted | | Mean | Standard Deviation | beat/min | | The vital signs collected between 5 to 60 minutes before and after the PET scan. | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| 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. | | Posted | | Mean | Standard Deviation | breaths/min | | The vital signs collected between 5 to 60 minutes before and after the PET scan. | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| 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. | | Posted | | Mean | Standard Deviation | degrees Celsius | | The vital signs collected between 5 to 60 minutes before and after the PET scan. | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |