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18F fluciclovine · 2 trials · 1 indication
Subject-level PPA and NPA (equivalent to sensitivity and specificity, respectively) of 18F-fluciclovinePET in detecting recurrent brain metastases.
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 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
| Arm | Type | Description |
|---|---|---|
| Patients | EXPERIMENTAL | Single intravenous administration of 18F fluciclovine for PET Scan |
| Name | Type | Description |
|---|---|---|
| 18F fluciclovine | DRUG | 18F fluciclovine injection, 185 MBq (5 mCi) ± 20%, delivered as an intravenous bolus |
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. Pr...
18F fluciclovine is an investigational small molecule being studied for use in brain metastases, specifically for detecting recurrent brain metastases with PET imaging. It is in Phase 3 clinical development and is not yet approved by the FDA. Two clinical trials have been completed to evaluate its diagnostic performance.
18F fluciclovine is a radiotracer used in PET imaging. It targets amino acid transport, which is upregulated in cancer cells, allowing visualization of recurrent brain metastases. The drug is taken up by tumor cells via amino acid transporters, enabling detection on PET scans.
18F fluciclovine is being developed by Precision BioSciences, Inc., a biopharmaceutical company traded on NASDAQ under the ticker DTIL. The company is conducting clinical trials to evaluate the drug's diagnostic performance in detecting recurrent brain metastases.
18F fluciclovine is in Phase 3 clinical development for brain metastases. It is an investigational drug and has not been approved by the FDA. Two trials have been completed, including a Phase 3 study with 151 participants and a Phase 2 study with 23 participants.
18F fluciclovine has been studied in two completed trials. NCT04410133 is a Phase 3 study evaluating its diagnostic performance in detecting recurrent brain metastases, enrolling 151 participants. NCT04410367 is a Phase 2 study to establish image interpretation criteria, enrolling 23 participants. Both were conducted in the United States.
18F fluciclovine is also known as fluciclovine F 18, a radiolabeled amino acid analog used in PET imaging. It is being developed by Precision BioSciences for detecting recurrent brain metastases. The drug is not yet approved and remains in clinical development.