[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.
Visão geral do estudo
Status
Intervenção / Tratamento
Tipo de estudo
Inscrição (Estimado)
Estágio
- Fase 3
Contactos e Locais
Contato de estudo
- Nome: Sahar Khan, Clinical Project Manager, MBA, MS
- Número de telefone: 2484692985
- E-mail: sahar.khan@telixpharma.com
Estude backup de contato
- Nome: Sapna Shah, Senior Director, Clinical Operations, MD
- E-mail: sapna.shah@telixpharma.com
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Diagnóstico
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
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 |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Patient-Level Mean Dice Similarity Coefficient for Lesion Spatial Agreement Between Reduced-Dose and Full-Dose [18F]FET PET Images
Prazo: 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
Prazo: 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 resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Number of Participants With Adverse Events Following Administration of 740 MBq [18F]FET
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
- PET Imaging
- Tomografia por emissão de pósitrons
- Imagem de ressonância magnética
- Tumores cerebrais
- Metástases cerebrais
- Diagnóstico por imagem
- Pseudoprogressão
- otimização de dose
- Progressão Tumoral
- Utilidade clínica
- Neuro-Oncologia
- Desempenho de diagnóstico
- Metástases do Sistema Nervoso Central
- Necrose de Radiação
- RANO-BM
- Treatment-Related Changes
- Amino Acid PET
- Floretyrosine F 18
- [18F]FET PET
Termos MeSH relevantes adicionais
- Doenças Cerebrais
- Doenças do Sistema Nervoso Central
- Doenças do Sistema Nervoso
- Processos Patológicos
- Neoplasias por local
- Neoplasias
- Atributos da doença
- Neoplasias do Sistema Nervoso
- Neoplasias do Sistema Nervoso Central
- Condições Patológicas, Sinais e Sintomas
- Progressão da doença
- Neoplasias Cerebrais
- (18f) Fluoroetiltosina
Outros números de identificação do estudo
- 18F-TLX101-Px-301
Plano para dados de participantes individuais (IPD)
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