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

5 november 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Geschat)

381

Fase

  • Fase 3

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Contact Back-up

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Diagnostisch
  • Toewijzing: NVT
  • Interventioneel model: Opdracht voor een enkele groep
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Arm Group Label: [18F]FET PET Imaging
Geneesmiddel: 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

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Patient-Level Mean Dice Similarity Coefficient for Lesion Spatial Agreement Between Reduced-Dose and Full-Dose [18F]FET PET Images
Tijdsspanne: 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
Tijdsspanne: 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).

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Number of Participants With Adverse Events Following Administration of 740 MBq [18F]FET
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Telix Pharmaceuticals (Innovations) Pty Limited

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 december 2026

Primaire voltooiing (Geschat)

1 april 2028

Studie voltooiing (Geschat)

1 juli 2028

Studieregistratiedata

Eerst ingediend

21 oktober 2026

Eerst ingediend dat voldeed aan de QC-criteria

5 november 2026

Eerst geplaatst (Werkelijk)

12 november 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

12 november 2026

Laatste update ingediend die voldeed aan QC-criteria

5 november 2026

Laatst geverifieerd

1 november 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 18F-TLX101-Px-301

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Ja

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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