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Also known as Floretyrosine F 18 ([18F]FET)
Floretyrosine F 18 · 1 trial · 4 indications
The patient-level mean Dice Similarity Coefficient (DSC), derived from all evaluable lesions, will be used to assess lesion spatial agreement between each reduced-dose \[18F\]FET PET dataset and the full-dose reference scan. The DSC results will be used to identify the lowest \[18F\]FET dose demonstrating non-inferior lesion spatial agreement.
Sensitivity will be assessed for \[18F\]FET PET at the optimized dose for distinguishing tumor progression from treatment-related changes, using the Composite Standard of Truth (CSOT) as the reference standard.
| Arm | Type | Description |
|---|---|---|
| Arm Group Label: [18F]FET PET Imaging | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Floretyrosine F 18 ([18F]FET) | DRUG | Floretyrosine F 18 (\[18F\]FET) is an investigational amino acid positron emission tomography (PET) radiopharmaceutical administered as a single intravenous injection for diagnostic imaging. Participants in Part 1 receive 740 MBq (±10%) of \[18F\]FET to evaluate dose optimization through comparison of reconstructed reduced-dose and full-dose PET images. Participants in Part 2 receive \[18F\]FET at the optimized dose identified in Part 1 to evaluate its diagnostic performance for differentiating tumor progression from treatment-related changes in brain metastases with equivocal MRI findings following therapy |
Inclusion Criteria: * Adults ≥18 years of age at the time of informed consent. * Prior diagnosis of brain metastases from a histologically confirmed solid tumor. * At least one measurable intracranial lesion (≥10 mm longest diameter and/or ≥5 mm short axis) identified on MRI and assessed according ...