[18F]FET PET for Differentiating Tumor Progression vs Treatment-Related Changes in Brain Metastases (TLX101-Px)
A Phase 3, Open-label, Single-arm Study to Investigate the Utility of ([18F]FET) PET in Participants With Brain Metastases and Equivocal MRI Findings Following Therapy to Differentiate Between Intracranial Tumor and Treatment-related Changes
This Phase 3 study will evaluate whether [18F]Floretyrosine ([18F]FET) PET imaging can help distinguish active brain tumor growth from treatment-related changes in patients with brain metastases who have unclear MRI findings after treatment. The study has two parts. Part 1 will identify the lowest effective dose of [18F]FET PET that provides reliable imaging results. Part 2 will evaluate the accuracy of [18F]FET PET, using the optimized dose, for distinguishing tumor progression from treatment-related changes. Study results will be compared with information from follow-up imaging, clinical assessments, and, when available, tissue samples obtained during routine clinical care. The goal is to determine whether [18F]FET PET can improve diagnostic accuracy and support clinical decision-making for patients with brain metastases.
Descripción general del estudio
Estado
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- Fase 3
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Sahar Khan, Clinical Project Manager, MBA, MS
- Número de teléfono: 2484692985
- Correo electrónico: sahar.khan@telixpharma.com
Copia de seguridad de contactos de estudio
- Nombre: Sapna Shah, Senior Director, Clinical Operations, MD
- Correo electrónico: sapna.shah@telixpharma.com
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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 to RANO-BM criteria.
- Target lesion considered equivocal for tumor progression versus treatment-related changes on MRI within 1 month prior to Day 1.
- Prior receipt of CNS-directed therapy for brain metastases within 12 months before Day 1.
- Planned standard-of-care management including biopsy/neurosurgical intervention and/or clinical follow-up MRI within 2 to 3 months after Day 1.
- ECOG Performance Status 0-2.
- Life expectancy of at least 3 months.
- Willing and able to provide written informed consent and comply with study procedures.
Exclusion Criteria:
- Serious non-malignant disease that may interfere with study objectives, safety, or compliance.
- Known hypersensitivity to [18F]FET or tyrosine derivatives.
- Ongoing Grade 3 toxicity from previous therapies.
- Exposure to a diagnostic or therapeutic radiopharmaceutical within protocol-specified washout periods.
- Whole brain radiotherapy or stereotactic radiosurgery within 2 months prior to Day 1.
- Exposure to another investigational agent within 30 days prior to Day 1 or participation in a conflicting clinical study.
- Absence of at least one measurable intracranial lesion.
- Contraindication to PET, CT, or MRI procedures.
- Inability to undergo required imaging procedures or comply with study requirements.
- Pregnant or breastfeeding women.
- Any condition that, in the investigator's opinion, would make the participant unsuitable for the study.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Diagnóstico
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Arm Group Label: [18F]FET PET Imaging
|
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 |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Patient-Level Mean Dice Similarity Coefficient for Lesion Spatial Agreement Between Reduced-Dose and Full-Dose [18F]FET PET Images
Periodo de tiempo: From Day 1 through Day 2 (±1 day) follow-up
|
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. |
From Day 1 through Day 2 (±1 day) follow-up
|
|
Sensitivity of [18F]FET PET for Distinguishing Tumor Progression From Treatment-Related Changes Compared With CSOT
Periodo de tiempo: From baseline Day 1 through CSOT determination (approximately 2-3 months).
|
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. |
From baseline Day 1 through CSOT determination (approximately 2-3 months).
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Number of Participants With Adverse Events Following Administration of 740 MBq [18F]FET
Periodo de tiempo: From Day 1 through Day 2 (±1 day) follow-up
|
The incidence and severity of adverse events and other safety findings will be assessed following administration of 740 MBq (±10%) [18F]FET PET |
From Day 1 through Day 2 (±1 day) follow-up
|
|
Inter-Reader Agreement for [18F]FET PET Classification at the Optimized Dose
Periodo de tiempo: Baseline Day 1 through completion of image interpretation following CSOT determination (approximately 2-3 months
|
Inter-reader agreement will be assessed for interpretation of [18F]FET PET images obtained at the optimized dose. |
Baseline Day 1 through completion of image interpretation following CSOT determination (approximately 2-3 months
|
|
Lesion-Level Sensitivity of [18F]FET PET for Distinguishing Tumor Progression From Treatment-Related Changes
Periodo de tiempo: From baseline Day 1 through CSOT determination, approximately 2-3 months
|
Sensitivity will be assessed at the lesion level for distinguishing tumor progression from treatment-related changes |
From baseline Day 1 through CSOT determination, approximately 2-3 months
|
|
Sensitivity of [18F]FET PET Compared With Histopathologic Confirmation
Periodo de tiempo: From baseline Day 1 through histopathologic confirmation, approximately 2-3 months
|
Sensitivity of [18F]FET PET will be assessed using histopathologic confirmation as the reference in participants with available histopathology. |
From baseline Day 1 through histopathologic confirmation, approximately 2-3 months
|
|
Positive Predictive Value of [18F]FET PET for Tumor Progression Compared With CSOT
Periodo de tiempo: From baseline Day 1 through CSOT determination, approximately 2-3 months
|
Positive predictive value will be assessed for [18F]FET PET classification of tumor progression using the Composite Standard of Truth (CSOT) as the reference standard |
From baseline Day 1 through CSOT determination, approximately 2-3 months
|
|
Negative Predictive Value of [18F]FET PET for Tumor Progression Compared With CSOT
Periodo de tiempo: From baseline Day 1 through CSOT determination, approximately 2-3 months
|
Negative predictive value will be assessed for [18F]FET PET classification of tumor progression using the Composite Standard of Truth (CSOT) as the reference standard. |
From baseline Day 1 through CSOT determination, approximately 2-3 months
|
|
Maximum Standardized Uptake Value (SUVmax) of [18F]FET PET Lesions
Periodo de tiempo: Baseline Day 1 imaging assessment
|
SUVmax will be measured for evaluable lesions on [18F]FET PET. |
Baseline Day 1 imaging assessment
|
|
Mean Standardized Uptake Value (SUVmean) of [18F]FET PET Lesions
Periodo de tiempo: Baseline Day 1 imaging assessment
|
SUVmean will be measured for evaluable lesions on [18F]FET PET. |
Baseline Day 1 imaging assessment
|
|
Maximum Tumor-to-Brain Ratio (TBRmax) of [18F]FET PET Lesions
Periodo de tiempo: Baseline Day 1 imaging assessment
|
TBRmax will be measured for evaluable lesions on [18F]FET PET. |
Baseline Day 1 imaging assessment
|
|
Mean Tumor-to-Brain Ratio (TBRmean) of [18F]FET PET Lesions
Periodo de tiempo: Baseline Day 1 imaging assessment
|
TBRmean will be measured for evaluable lesions on [18F]FET PET. |
Baseline Day 1 imaging assessment
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) at the Optimized Dose
Periodo de tiempo: From Day 1 administration through study completion, approximately 5-6 months
|
Safety and tolerability at the optimized dose will be assessed by the number of participants experiencing treatment-emergent adverse events (TEAEs), including serious adverse events (SAEs), adverse events leading to treatment discontinuation, and treatment-related adverse events, as applicable. Adverse events will be assessed and graded according to the protocol-specified safety assessment criteria. |
From Day 1 administration through study completion, approximately 5-6 months
|
Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
- Imágenes PET
- Tomografía de emisión de positrones
- Imagen de resonancia magnética
- Tumores cerebrales
- Metástasis cerebrales
- Diagnóstico por imagen
- Pseudoprogresión
- optimización de dosis
- Progresión tumoral
- Utilidad Clínica
- Neuro-Oncología
- Rendimiento de diagnóstico
- Metástasis del Sistema Nervioso Central
- Necrosis por radiación
- RANO-BM
- Treatment-Related Changes
- Amino Acid PET
- Floretyrosine F 18
- [18F]FET PET
Términos MeSH relevantes adicionales
- Enfermedades Cerebrales
- Enfermedades del Sistema Nervioso Central
- Enfermedades del Sistema Nervioso
- Procesos Patológicos
- Neoplasias por sitio
- Neoplasias
- Atributos de la enfermedad
- Neoplasias del Sistema Nervioso
- Neoplasias del Sistema Nervioso Central
- Condiciones Patológicas, Signos y Síntomas
- Enfermedad progresiva
- Neoplasias Cerebrales
- (18F) fluoroetiltyrosina
Otros números de identificación del estudio
- 18F-TLX101-Px-301
Plan de datos de participantes individuales (IPD)
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Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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