Brain Metastases
Conditions
Keywords
Recurrent Brain Metastases, Diagnostic, Positron Emission Tomography (PET) Scan
Brief summary
An Open-label, Single-arm, Single-dose, Prospective, Multicenter Phase 2b Study to Establish Image Interpretation Criteria for 18F-Fluciclovine Positron Emission Tomography (PET) in Detecting Recurrent Brain Metastases After Radiation Therapy
Interventions
DRUG18F fluciclovine
18F fluciclovine injection, 185 MegaBecquerel (MBq) (5 Millicurie (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 0-2 2. Previous history of solid tumor brain metastasis of any origin 3. Histopathological confirmation of the primary solid tumor or a metastatic site 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 craniotomy
Exclusion criteria
1\. Patients with a history of active hematological malignancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity of 18F Fluciclovine PET for Detecting Recurrent Brain Metastases at Different Visual Thresholds | 60 days | Sensitivity is calculated as % of participants with positive histopathology who are classified as positive on their 18F fluciclovine PET (i.e. true positive). Each participant had one lesion, therefore results are representative of both subject and lesion level sensitivity. Three readers evaluated the PET scans to classify 18F fluciclovine uptake in study lesions according to 4 incremental categories: absent, mild, moderate or marked. Three different thresholds of 18F fluciclovine uptake were then applied to calculate the sensitivity: Mild or Higher Uptake, Moderate or Higher Uptake, Marked Uptake. As an example, for calculating sensitivity based on the threshold of Mild or Higher Uptake, all participants with positive histopathology, classified by a reader as having mild, moderate or marked 18F fluciclovine uptake, would be categorized as true positive. This calculation was then repeated on the other two threshold categories, to produce sensitivities at different thresholds. |
| Specificity of 18F Fluciclovine PET for Detecting Recurrent Brain Metastases at Different Visual Thresholds | 60 days | Specificity is calculated as the % of participants with negative histopathology who are classified as negative on their 18F fluciclovine PET (i.e. true negative). Each participant had 1 lesion, therefore results are representative of both subject and lesion level specificity. 3 readers evaluated the PET scans to classify 18F fluciclovine uptake in study lesions according to 4 incremental categories: absent, mild, moderate or marked. 3 different thresholds of uptake were then applied to calculate the specificity: Mild or Higher Uptake, Moderate or Higher Uptake, Marked Uptake. Example, for calculating specificity based on the threshold of Moderate or Higher Uptake, all participants with negative histopath, classified by a reader as having absent or mild uptake (i.e. not classified by a reader as having moderate or marked uptake), would be categorized as true negative. This calculation was repeated on the other 2 threshold categories, to produce specificities at different thresholds |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity of 18F Fluciclovine PET for Detecting Recurrent Brain Metastases Based on Quantitative and Dynamic Measures of Lesion 18F Fluciclovine Uptake | 60 days | Sensitivity calculated as %participants with positive histopath and positive on PET (i.e. true positive). Each participant had 1 lesion, results represent both subject and lesion level sensitivity. Sensitivity is calculated using positive PET classified by quantitative and dynamic measures. Quantitative measure is based on lesion standardized uptake value (SUV). Receiver Operating Characteristic (ROC) analysis of all participant lesion SUV was performed. ROC analyses was performed to select a SUV threshold for calculating sensitivity. Sensitivity calculation: participants with positive histopath and SUV = or \> threshold are positive on scan. Dynamic measure: 3 readers evaluated PET scans to classify uptake pattern based on 4 categories: Type 0, Type I, Type II, Type III. Sensitivity is calculated for each type of uptake pattern (example: calculating sensitivity based on Type I pattern, participants with positive histopath, classified as Type I, would be categorized as true positive). |
| Specificity of Different Thresholds of Quantitative and Dynamic Measures of Lesion 18F Fluciclovine Uptake. | 60 days | Specificity is calculated as %participants with negative histopath and negative on PET (i.e. true negative). Each participant had 1 lesion, results represent both subject and lesion level specificity. Specificity is calculated using negative PET classified by quantitative and dynamic measures. Quantitative measure is based on lesion standardized uptake value (SUV). Receiver Operating Characteristic (ROC) analysis of all participant lesion SUV was performed. ROC analyses was performed to select a SUV threshold for calculating sensitivity. Specificity calculation: participants with negative histopath, SUV \< threshold are negative on scan. Dynamic measure: 3 readers evaluated PET scans to classify uptake pattern based on 4 categories: Type 0, Type I, Type II, Type III. Specificity is calculated for each type of uptake pattern (example, calculating specificity based on Type I pattern, participants with negative histopath, classified as Type I, would be categorized as true negative) |
| Treatment-emergent Adverse Events | From the time of administration of 18F fluciclovine until 1 day post-18F-fluciclovine administration. | 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 1 day post-18F-fluciclovine administration. |
Countries
United States
Participant flow
Recruitment details
Subjects with a history of brain metastases previously treated with primary, adjuvant, or repeat (salvage) radiation therapy, with a recent standard of care (SoC) brain magnetic resonance imaging (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. Subjects were screened between 28Oct2020 and 30Dec2021. Nine clinical research sites in the US participated in the study.
Pre-assignment details
On-study site investigators prospectively annotated and measured the 'reference lesion' on a postradiation treatment MRI scan and on the SoC MRI brain scan to confirm eligibility. The 'reference lesion' was defined as the lesion which was Equivocal for recurrent metastasis on SoC MRI, Intended for pre-planned SoC craniotomy, and If \> 1 equivocal lesion was intended for resection, the largest of these lesions.
Participants by arm
| Arm | Count |
|---|---|
| Patients Single intravenous administration of 18F fluciclovine for PET Scan
18F fluciclovine: 18F fluciclovine injection, 185 MBq (5 mCi) ± 20%, delivered as an intravenous bolus | 23 |
| Total | 23 |
Baseline characteristics
| Characteristic | Patients |
|---|---|
| Age, Continuous | 59.8 years STANDARD_DEVIATION 11.88 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 8 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 15 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 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 | 1 Participants |
| Race (NIH/OMB) White | 20 Participants |
| Region of Enrollment United States | 23 participants |
| Sex: Female, Male Female | 16 Participants |
| Sex: Female, Male Male | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 23 |
| other Total, other adverse events | 1 / 23 |
| serious Total, serious adverse events | 0 / 23 |
Outcome results
Primary
Sensitivity of 18F Fluciclovine PET for Detecting Recurrent Brain Metastases at Different Visual Thresholds
Sensitivity is calculated as % of participants with positive histopathology who are classified as positive on their 18F fluciclovine PET (i.e. true positive). Each participant had one lesion, therefore results are representative of both subject and lesion level sensitivity. Three readers evaluated the PET scans to classify 18F fluciclovine uptake in study lesions according to 4 incremental categories: absent, mild, moderate or marked. Three different thresholds of 18F fluciclovine uptake were then applied to calculate the sensitivity: Mild or Higher Uptake, Moderate or Higher Uptake, Marked Uptake. As an example, for calculating sensitivity based on the threshold of Mild or Higher Uptake, all participants with positive histopathology, classified by a reader as having mild, moderate or marked 18F fluciclovine uptake, would be categorized as true positive. This calculation was then repeated on the other two threshold categories, to produce sensitivities at different thresholds.
Time frame: 60 days
Population: Sensitivity analysis (%) based on 10 subjects with positive lesions per standard of truth (central histopathological analysis).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 18F-Fluciclovine Injection | Sensitivity of 18F Fluciclovine PET for Detecting Recurrent Brain Metastases at Different Visual Thresholds | Mild or Higher Uptake = Positive : Central Reader 2 | 100 percentage of participants |
| 18F-Fluciclovine Injection | Sensitivity of 18F Fluciclovine PET for Detecting Recurrent Brain Metastases at Different Visual Thresholds | Moderate or Higher Uptake = Positive : Central Reader 1 | 100 percentage of participants |
| 18F-Fluciclovine Injection | Sensitivity of 18F Fluciclovine PET for Detecting Recurrent Brain Metastases at Different Visual Thresholds | Moderate or Higher Uptake = Positive : Central Reader 3 | 90 percentage of participants |
| 18F-Fluciclovine Injection | Sensitivity of 18F Fluciclovine PET for Detecting Recurrent Brain Metastases at Different Visual Thresholds | Marked Uptake = Positive : Central Reader 1 | 80 percentage of participants |
| 18F-Fluciclovine Injection | Sensitivity of 18F Fluciclovine PET for Detecting Recurrent Brain Metastases at Different Visual Thresholds | Marked Uptake = Positive : Central Reader 2 | 40 percentage of participants |
| 18F-Fluciclovine Injection | Sensitivity of 18F Fluciclovine PET for Detecting Recurrent Brain Metastases at Different Visual Thresholds | Marked Uptake = Positive : Central Reader 3 | 60 percentage of participants |
| 18F-Fluciclovine Injection | Sensitivity of 18F Fluciclovine PET for Detecting Recurrent Brain Metastases at Different Visual Thresholds | Mild or Higher Uptake = Positive : Central Reader 1 | 100 percentage of participants |
| 18F-Fluciclovine Injection | Sensitivity of 18F Fluciclovine PET for Detecting Recurrent Brain Metastases at Different Visual Thresholds | Mild or Higher Uptake = Positive : Central Reader 3 | 100 percentage of participants |
| 18F-Fluciclovine Injection | Sensitivity of 18F Fluciclovine PET for Detecting Recurrent Brain Metastases at Different Visual Thresholds | Moderate or Higher Uptake = Positive : Central Reader 2 | 100 percentage of participants |
Primary
Specificity of 18F Fluciclovine PET for Detecting Recurrent Brain Metastases at Different Visual Thresholds
Specificity is calculated as the % of participants with negative histopathology who are classified as negative on their 18F fluciclovine PET (i.e. true negative). Each participant had 1 lesion, therefore results are representative of both subject and lesion level specificity. 3 readers evaluated the PET scans to classify 18F fluciclovine uptake in study lesions according to 4 incremental categories: absent, mild, moderate or marked. 3 different thresholds of uptake were then applied to calculate the specificity: Mild or Higher Uptake, Moderate or Higher Uptake, Marked Uptake. Example, for calculating specificity based on the threshold of Moderate or Higher Uptake, all participants with negative histopath, classified by a reader as having absent or mild uptake (i.e. not classified by a reader as having moderate or marked uptake), would be categorized as true negative. This calculation was repeated on the other 2 threshold categories, to produce specificities at different thresholds
Time frame: 60 days
Population: Specificity analysis (%) based on 13 subjects with negative lesions per standard of truth (central histopathological analysis).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 18F-Fluciclovine Injection | Specificity of 18F Fluciclovine PET for Detecting Recurrent Brain Metastases at Different Visual Thresholds | Moderate or Higher Uptake = Positive : Central Reader 1 | 38.5 percentage of participants |
| 18F-Fluciclovine Injection | Specificity of 18F Fluciclovine PET for Detecting Recurrent Brain Metastases at Different Visual Thresholds | Mild or Higher Uptake = Positive : Central Reader 1 | 0 percentage of participants |
| 18F-Fluciclovine Injection | Specificity of 18F Fluciclovine PET for Detecting Recurrent Brain Metastases at Different Visual Thresholds | Mild or Higher Uptake = Positive : Central Reader 2 | 0 percentage of participants |
| 18F-Fluciclovine Injection | Specificity of 18F Fluciclovine PET for Detecting Recurrent Brain Metastases at Different Visual Thresholds | Mild or Higher Uptake = Positive : Central Reader 3 | 0 percentage of participants |
| 18F-Fluciclovine Injection | Specificity of 18F Fluciclovine PET for Detecting Recurrent Brain Metastases at Different Visual Thresholds | Moderate or Higher Uptake = Positive : Central Reader 2 | 30.8 percentage of participants |
| 18F-Fluciclovine Injection | Specificity of 18F Fluciclovine PET for Detecting Recurrent Brain Metastases at Different Visual Thresholds | Moderate or Higher Uptake = Positive : Central Reader 3 | 46.2 percentage of participants |
| 18F-Fluciclovine Injection | Specificity of 18F Fluciclovine PET for Detecting Recurrent Brain Metastases at Different Visual Thresholds | Marked Uptake = Positive : Central Reader 1 | 92.3 percentage of participants |
| 18F-Fluciclovine Injection | Specificity of 18F Fluciclovine PET for Detecting Recurrent Brain Metastases at Different Visual Thresholds | Marked Uptake = Positive : Central Reader 2 | 100 percentage of participants |
| 18F-Fluciclovine Injection | Specificity of 18F Fluciclovine PET for Detecting Recurrent Brain Metastases at Different Visual Thresholds | Marked Uptake = Positive : Central Reader 3 | 100 percentage of participants |
Secondary
Sensitivity of 18F Fluciclovine PET for Detecting Recurrent Brain Metastases Based on Quantitative and Dynamic Measures of Lesion 18F Fluciclovine Uptake
Sensitivity calculated as %participants with positive histopath and positive on PET (i.e. true positive). Each participant had 1 lesion, results represent both subject and lesion level sensitivity. Sensitivity is calculated using positive PET classified by quantitative and dynamic measures. Quantitative measure is based on lesion standardized uptake value (SUV). Receiver Operating Characteristic (ROC) analysis of all participant lesion SUV was performed. ROC analyses was performed to select a SUV threshold for calculating sensitivity. Sensitivity calculation: participants with positive histopath and SUV = or \> threshold are positive on scan. Dynamic measure: 3 readers evaluated PET scans to classify uptake pattern based on 4 categories: Type 0, Type I, Type II, Type III. Sensitivity is calculated for each type of uptake pattern (example: calculating sensitivity based on Type I pattern, participants with positive histopath, classified as Type I, would be categorized as true positive).
Time frame: 60 days
Population: Sensitivity analysis (%) based on 10 subjects with positive lesions per standard of truth.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 18F-Fluciclovine Injection | Sensitivity of 18F Fluciclovine PET for Detecting Recurrent Brain Metastases Based on Quantitative and Dynamic Measures of Lesion 18F Fluciclovine Uptake | Dynamic Type 0 : Central Reader 3 | 0 percentage of participants |
| 18F-Fluciclovine Injection | Sensitivity of 18F Fluciclovine PET for Detecting Recurrent Brain Metastases Based on Quantitative and Dynamic Measures of Lesion 18F Fluciclovine Uptake | Dynamic Type III: Central Reader 3 | 0 percentage of participants |
| 18F-Fluciclovine Injection | Sensitivity of 18F Fluciclovine PET for Detecting Recurrent Brain Metastases Based on Quantitative and Dynamic Measures of Lesion 18F Fluciclovine Uptake | Quantitative SUV ≥ 4.8 = Positive : Central Reader 1 | 80 percentage of participants |
| 18F-Fluciclovine Injection | Sensitivity of 18F Fluciclovine PET for Detecting Recurrent Brain Metastases Based on Quantitative and Dynamic Measures of Lesion 18F Fluciclovine Uptake | Quantitative SUV ≥ 4.8 = Positive : Central Reader 2 | 80 percentage of participants |
| 18F-Fluciclovine Injection | Sensitivity of 18F Fluciclovine PET for Detecting Recurrent Brain Metastases Based on Quantitative and Dynamic Measures of Lesion 18F Fluciclovine Uptake | Quantitative SUV ≥ 4.8 = Positive : Central Reader 3 | 80 percentage of participants |
| 18F-Fluciclovine Injection | Sensitivity of 18F Fluciclovine PET for Detecting Recurrent Brain Metastases Based on Quantitative and Dynamic Measures of Lesion 18F Fluciclovine Uptake | Dynamic Type 0: Central Reader 1 | 0 percentage of participants |
| 18F-Fluciclovine Injection | Sensitivity of 18F Fluciclovine PET for Detecting Recurrent Brain Metastases Based on Quantitative and Dynamic Measures of Lesion 18F Fluciclovine Uptake | Dynamic Type 0 : Central Reader 2 | 0 percentage of participants |
| 18F-Fluciclovine Injection | Sensitivity of 18F Fluciclovine PET for Detecting Recurrent Brain Metastases Based on Quantitative and Dynamic Measures of Lesion 18F Fluciclovine Uptake | Dynamic Type I: Central Reader 1 | 80 percentage of participants |
| 18F-Fluciclovine Injection | Sensitivity of 18F Fluciclovine PET for Detecting Recurrent Brain Metastases Based on Quantitative and Dynamic Measures of Lesion 18F Fluciclovine Uptake | Dynamic Type I: Central Reader 2 | 90 percentage of participants |
| 18F-Fluciclovine Injection | Sensitivity of 18F Fluciclovine PET for Detecting Recurrent Brain Metastases Based on Quantitative and Dynamic Measures of Lesion 18F Fluciclovine Uptake | Dynamic Type I: Central Reader 3 | 100 percentage of participants |
| 18F-Fluciclovine Injection | Sensitivity of 18F Fluciclovine PET for Detecting Recurrent Brain Metastases Based on Quantitative and Dynamic Measures of Lesion 18F Fluciclovine Uptake | Dynamic Type II: Central Reader 1 | 10 percentage of participants |
| 18F-Fluciclovine Injection | Sensitivity of 18F Fluciclovine PET for Detecting Recurrent Brain Metastases Based on Quantitative and Dynamic Measures of Lesion 18F Fluciclovine Uptake | Dynamic Type II: Central Reader 2 | 10 percentage of participants |
| 18F-Fluciclovine Injection | Sensitivity of 18F Fluciclovine PET for Detecting Recurrent Brain Metastases Based on Quantitative and Dynamic Measures of Lesion 18F Fluciclovine Uptake | Dynamic Type II: Central Reader 3 | 0 percentage of participants |
| 18F-Fluciclovine Injection | Sensitivity of 18F Fluciclovine PET for Detecting Recurrent Brain Metastases Based on Quantitative and Dynamic Measures of Lesion 18F Fluciclovine Uptake | Dynamic Type III: Central Reader 1 | 10 percentage of participants |
| 18F-Fluciclovine Injection | Sensitivity of 18F Fluciclovine PET for Detecting Recurrent Brain Metastases Based on Quantitative and Dynamic Measures of Lesion 18F Fluciclovine Uptake | Dynamic Type III: Central Reader 2 | 0 percentage of participants |
Secondary
Specificity of Different Thresholds of Quantitative and Dynamic Measures of Lesion 18F Fluciclovine Uptake.
Specificity is calculated as %participants with negative histopath and negative on PET (i.e. true negative). Each participant had 1 lesion, results represent both subject and lesion level specificity. Specificity is calculated using negative PET classified by quantitative and dynamic measures. Quantitative measure is based on lesion standardized uptake value (SUV). Receiver Operating Characteristic (ROC) analysis of all participant lesion SUV was performed. ROC analyses was performed to select a SUV threshold for calculating sensitivity. Specificity calculation: participants with negative histopath, SUV \< threshold are negative on scan. Dynamic measure: 3 readers evaluated PET scans to classify uptake pattern based on 4 categories: Type 0, Type I, Type II, Type III. Specificity is calculated for each type of uptake pattern (example, calculating specificity based on Type I pattern, participants with negative histopath, classified as Type I, would be categorized as true negative)
Time frame: 60 days
Population: Subjects who have been dosed with 18F-Fluciclovine, have an evaluable on-study PET scan, and negative histopathology.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 18F-Fluciclovine Injection | Specificity of Different Thresholds of Quantitative and Dynamic Measures of Lesion 18F Fluciclovine Uptake. | SUV ≥ 4.8 : Central Reader 1 | 84.6 percentage of participants |
| 18F-Fluciclovine Injection | Specificity of Different Thresholds of Quantitative and Dynamic Measures of Lesion 18F Fluciclovine Uptake. | SUV ≥ 4.8 : Central Reader 2 | 84.6 percentage of participants |
| 18F-Fluciclovine Injection | Specificity of Different Thresholds of Quantitative and Dynamic Measures of Lesion 18F Fluciclovine Uptake. | SUV ≥ 4.8 : Central Reader 3 | 84.6 percentage of participants |
| 18F-Fluciclovine Injection | Specificity of Different Thresholds of Quantitative and Dynamic Measures of Lesion 18F Fluciclovine Uptake. | Dynamic Type 0 : Central Reader 1 | 100 percentage of participants |
| 18F-Fluciclovine Injection | Specificity of Different Thresholds of Quantitative and Dynamic Measures of Lesion 18F Fluciclovine Uptake. | Dynamic Type 0 : Central Reader 2 | 100 percentage of participants |
| 18F-Fluciclovine Injection | Specificity of Different Thresholds of Quantitative and Dynamic Measures of Lesion 18F Fluciclovine Uptake. | Dynamic Type 0 : Central Reader 3 | 100 percentage of participants |
| 18F-Fluciclovine Injection | Specificity of Different Thresholds of Quantitative and Dynamic Measures of Lesion 18F Fluciclovine Uptake. | Dynamic Type I : Central Reader 1 | 7.7 percentage of participants |
| 18F-Fluciclovine Injection | Specificity of Different Thresholds of Quantitative and Dynamic Measures of Lesion 18F Fluciclovine Uptake. | Dynamic Type I : Central Reader 2 | 15.4 percentage of participants |
| 18F-Fluciclovine Injection | Specificity of Different Thresholds of Quantitative and Dynamic Measures of Lesion 18F Fluciclovine Uptake. | Dynamic Type I : Central Reader 3 | 0 percentage of participants |
| 18F-Fluciclovine Injection | Specificity of Different Thresholds of Quantitative and Dynamic Measures of Lesion 18F Fluciclovine Uptake. | Dynamic Type II : Central Reader 1 | 92.3 percentage of participants |
| 18F-Fluciclovine Injection | Specificity of Different Thresholds of Quantitative and Dynamic Measures of Lesion 18F Fluciclovine Uptake. | Dynamic Type II : Central Reader 2 | 84.6 percentage of participants |
| 18F-Fluciclovine Injection | Specificity of Different Thresholds of Quantitative and Dynamic Measures of Lesion 18F Fluciclovine Uptake. | Dynamic Type II : Central Reader 3 | 100 percentage of participants |
| 18F-Fluciclovine Injection | Specificity of Different Thresholds of Quantitative and Dynamic Measures of Lesion 18F Fluciclovine Uptake. | Dynamic Type III : Central Reader 1 | 100 percentage of participants |
| 18F-Fluciclovine Injection | Specificity of Different Thresholds of Quantitative and Dynamic Measures of Lesion 18F Fluciclovine Uptake. | Dynamic Type III : Central Reader 2 | 100 percentage of participants |
| 18F-Fluciclovine Injection | Specificity of Different Thresholds of Quantitative and Dynamic Measures of Lesion 18F Fluciclovine Uptake. | Dynamic Type III : Central Reader 3 | 100 percentage of participants |
Secondary
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 1 day post-18F-fluciclovine administration.
Time frame: From the time of administration of 18F fluciclovine until 1 day post-18F-fluciclovine administration.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 18F-Fluciclovine Injection | Treatment-emergent Adverse Events | Subjects reporting at least 1 TEAE | 1 Participants |
| 18F-Fluciclovine Injection | Treatment-emergent Adverse Events | Nervous System Disorders (Headache) | 1 Participants |