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

5. november 2026 oppdatert av: 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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

381

Fase

  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Diagnostisk
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Arm Group Label: [18F]FET PET Imaging
Legemiddel: 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

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Patient-Level Mean Dice Similarity Coefficient for Lesion Spatial Agreement Between Reduced-Dose and Full-Dose [18F]FET PET Images
Tidsramme: 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
Tidsramme: 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).

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Number of Participants With Adverse Events Following Administration of 740 MBq [18F]FET
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Telix Pharmaceuticals (Innovations) Pty Limited

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. desember 2026

Primær fullføring (Antatt)

1. april 2028

Studiet fullført (Antatt)

1. juli 2028

Datoer for studieregistrering

Først innsendt

21. oktober 2026

Først innsendt som oppfylte QC-kriteriene

5. november 2026

Først lagt ut (Faktiske)

12. november 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

12. november 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

5. november 2026

Sist bekreftet

1. november 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 18F-TLX101-Px-301

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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