[18F]FTT Positron Emission Tomography/Computed Tomography to Predict Treatment Response in Patients Scheduled to Receive Gemcitabine, Cisplatin, and Durvalumab for Newly Diagnosed Cholangiocarcinoma
12 de agosto de 2026 actualizado por: University of Washington
Imaging PARP Expression in Cholangiocarcinoma
This phase II trial studies whether [18F]FTT can be used with positron emission tomography (PET)/computed tomography (CT) imaging to predict treatment response in patients scheduled to receive gemcitabine, cisplatin, and durvalumab (GCD) for newly diagnosed cholangiocarcinoma.
PET/CT is an imaging technique that utilizes PET and CT in a single machine.
PET is an established imaging technique that utilizes small amounts of radioactivity attached to very minimal amounts of tracer, in the case of this trial, [18F]FTT, to make detailed, computerized pictures of areas inside the body where the tracer is used.
CT utilizes x-rays that traverse body from the outside.
CT images provide an exact outline of organs and potential inflammatory tissue where it occurs in the patient's body.
[18F]FTT targets and binds to poly (ADP-ribose) polymerase 1 (PARP1).
Some cholangiocarcinoma tumor cells may express PARP1 which may make it easier to see them on PET/CT.
Research has shown that tumor cells that express PARP1 may not respond well to GCD treatment.
Researchers hope that by using [18F]FTT with PET/CT imaging they will be able to detect which patients have tumor cells that express PARP1, which may help predict treatment response in patients scheduled to receive GCD for newly diagnosed cholangiocarcinoma.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Descripción detallada
OUTLINE:
Patients receive [18F]FTT intravenously (IV) and 60, 90, or 150 minutes later undergo PET/CT within 30 days prior to day 1 cycle 1 of GCD and 12 weeks after starting GCD in the absence of unacceptable toxicity. Patients also undergo CT and/or magnetic resonance imaging (MRI) throughout the study.
After completion of study intervention, patients are followed up at week 24 and then up to 6 months after completing GCD treatment.
Tipo de estudio
Intervencionista
Inscripción (Estimado)
22
Fase
- Fase 2
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Angela Castellanos Rodriguez, MD, MSc
- Número de teléfono: 206-606-6777
- Correo electrónico: acastell@uw.edu
Ubicaciones de estudio
-
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Washington
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Seattle, Washington, Estados Unidos, 98109
- Fred Hutch/University of Washington Cancer Consortium
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Contacto:
- Angela Castellanos Rodriguez, MD, MSc
- Número de teléfono: 206-606-6777
- Correo electrónico: acastell@uw.edu
-
Investigador principal:
- Angela Castellanos Rodriguez, MD, MSc
-
-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
Inclusion Criteria:
- Patient must have histologically confirmed cholangiocarcinoma
- Patient must be newly diagnosed and have not yet been treated
- Patient planned to receive GCD per standard-of-care
- Patient must have evaluable disease or at least one measurable lesion that can be assessed at baseline by CT (or MRI) per RECIST 1.1
- Age ≥ 18 years
- For women of childbearing potential, a negative serum pregnancy test is required within 7 days prior to [18F]FTT PET imaging
- Men and women of reproductive potential need to agree to employ acceptable forms of contraception throughout their participation in the study that meet requirements for GCD treatment per standard of care
- Patient is willing and able to comply with the protocol for the duration of the study including undergoing all study procedures
- Ability to understand and the willingness to sign a written informed consent document. Informed consent must be provided prior to any study specific procedures
Exclusion Criteria:
- Pregnant or breastfeeding women
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿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 |
|---|---|
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Experimental: Diagnostic ([18F]FTT PET/CT)
Patients receive [18F]FTT IV and 60, 90, or 150 minutes later undergo PET/CT within 30 days prior to day 1 cycle 1 of GCD and 12 weeks after starting GCD in the absence of unacceptable toxicity.
Patients also undergo CT and/or MRI throughout the study.
|
Someterse a una resonancia magnética
Otros nombres:
Someterse a PET/CT
Otros nombres:
Dado IV
Otros nombres:
Someterse a PET/CT y/o CT
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Relationship between standardized uptake value maximum (SUVmax) and overall response rate
Periodo de tiempo: At baseline and 24 weeks after starting gemcitabine, cisplatin, and durvalumab (GCD)
|
Baseline SUVmax will be extracted from a region of interest (ROI) placed on the tumor lesion of interest using a 40% threshold.
Will assess overall response rate at 24 ± 2 weeks after starting GCD by using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria.
Response will be analyzed as a binary outcome.
Differences in baseline SUVmax between responders and non-responders will be evaluated using the Wilcoxon rank-sum test.
Logistic regression models will be used to estimate the direction and magnitude of association, with response as the dependent variable and SUVmax as the predictor.
Odds ratios and 95% confidence intervals will be reported.
Analysis will focus on estimation of effect sizes and the direction and magnitude of associations of the primary endpoints, overall response rate and SUVmax of the most avid lesion, rather than formal hypothesis testing alone.
Boxplots will be used to visualize the distribution of SUVmax by responders group.
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At baseline and 24 weeks after starting gemcitabine, cisplatin, and durvalumab (GCD)
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Relationship between standardized uptake value mean (SUVmean) and overall response rate
Periodo de tiempo: At baseline and 24 weeks after starting GCD
|
Will measure baseline SUVmean from an ROI placed on the tumor lesion of interest using a 40% threshold.
Treatment response will be defined by RECIST 1.1 criteria at 24 ± 2 weeks following GCD treatment.
Association between baseline SUVmean and treatment response will be evaluated using Wilcoxon rank-sum test.
Logistic regression will be used to quantify the magnitude and direction of association between baseline SUVmean and response.
Results will be summarized using odds ratios with 95% confidence intervals, and boxplot to illustrate the distribution of baseline SUVmean between responders and non-responders.
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At baseline and 24 weeks after starting GCD
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Change in SUVmax and response
Periodo de tiempo: Baseline to 12 weeks after starting GCD
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Will calculate the change of SUVmax from baseline to 12 ± 2 weeks after starting GCD.
Due to the limited sample size, will use the nonparametric method Wilcoxon Rank Sum test to evaluate the difference in change between responders and non-responders.
Effect sizes will be summarized using the median difference (Hodges-Lehmann estimator) in change between groups with 95% confidence intervals.
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Baseline to 12 weeks after starting GCD
|
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Change in SUVmean and response
Periodo de tiempo: Baseline to 12 weeks after starting GCD
|
Will calculate the change of SUVmean from baseline to 12 ± 2 weeks after starting GCD.
Due to the limited sample size, will use the nonparametric method Wilcoxon Rank Sum test to evaluate the difference in change between responders and non-responders.
Effect sizes will be summarized using the median difference (Hodges-Lehmann estimator) in change between groups with 95% confidence intervals.
|
Baseline to 12 weeks after starting GCD
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Angela Castellanos Rodriguez, MD, MSc, Fred Hutch/University of Washington Cancer Consortium
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
1 de noviembre de 2026
Finalización primaria (Estimado)
1 de julio de 2028
Finalización del estudio (Estimado)
31 de diciembre de 2028
Fechas de registro del estudio
Enviado por primera vez
22 de junio de 2026
Primero enviado que cumplió con los criterios de control de calidad
22 de junio de 2026
Publicado por primera vez (Actual)
29 de junio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
14 de agosto de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
12 de agosto de 2026
Última verificación
1 de junio de 2026
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- RG1126474
- NCI-2026-03509 (Identificador de registro: CTRP (Clinical Trial Reporting Program))
- FHIRB0021301 (Otro identificador: Fred Hutch/University of Washington Cancer Consortium)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Sí
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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