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[18F]FET PET for Differentiating Tumor Progression vs Treatment-Related Changes in Brain Metastases (TLX101-Px)

5 novembre 2026 aggiornato da: Telix Pharmaceuticals (Innovations) Pty Limited

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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Stimato)

381

Fase

  • Fase 3

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Diagnostico
  • Assegnazione: N / A
  • Modello interventistico: Assegnazione di gruppo singolo
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Arm Group Label: [18F]FET PET Imaging
Droga: Floretyrosine F 18 ([18F]FET)

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

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Patient-Level Mean Dice Similarity Coefficient for Lesion Spatial Agreement Between Reduced-Dose and Full-Dose [18F]FET PET Images
Lasso di tempo: 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
Lasso di tempo: 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).

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Number of Participants With Adverse Events Following Administration of 740 MBq [18F]FET
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Telix Pharmaceuticals (Innovations) Pty Limited

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 dicembre 2026

Completamento primario (Stimato)

1 aprile 2028

Completamento dello studio (Stimato)

1 luglio 2028

Date di iscrizione allo studio

Primo inviato

21 ottobre 2026

Primo inviato che soddisfa i criteri di controllo qualità

5 novembre 2026

Primo Inserito (Effettivo)

12 novembre 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

12 novembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

5 novembre 2026

Ultimo verificato

1 novembre 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 18F-TLX101-Px-301

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

Sì

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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