- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02511756
Visualization of Anti-angiogenic Effects With Perfusion Computed Tomography (CTP) (AVA-CTP)
Visualization of Anti-angiogenic Effects With Perfusion Computed Tomography (CTP) in mCRC Patients Treated With First-line Bevacizumab
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
So far, CTP has provided non-invasive imaging of tumor biological response to anti-angiogenic and vascular targeting agents in a number of clinical trials with increasing clinical application. CTP can be examined with a variety of commercially available CE-certified CT scanners and imaging post-processing is possible with commercially available CE-certified software from different vendors, too. In several studies, anti-angiogenic effects have been detected with CTP but further evidence for its clinical validation has to be proven in clinical trials.
Changes in tumor vasculature measured by CTP will be correlated to the clinical efficacy parameters progression-free survival, overall survival and response rate, thus identifying a group of patients who profit most from the anti-angiogenic treatment.
Tipo de estudio
Inscripción (Anticipado)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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-
GR
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Chur, GR, Suiza, 7000
- Kantonsspital Graubunden
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LU
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Luzern, LU, Suiza, 6000
- Luzerner Kantonsspital
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SG
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St. Gallen, SG, Suiza, 9007
- Kantonsspital St. Gallen
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ZH
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Winterthur, ZH, Suiza, 8401
- Kantonsspital Winterthur
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Zürich, ZH, Suiza, 8091
- Universitätsspital Zürich
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Age ≥ 18 years, male or female
- Signed written informed consent
- Patients with histologically confirmed diagnosis of colorectal cancer with hepatic metastases who are candidates for systemic treatment.
Confirmation of metastatic liver disease within one month prior to inclusion in one of the following radiological procedures:
- Contrast-enhanced spiral computed tomography showing at least one liver nodule ≥ 20 mm in longest diameter according to RECIST 1.1 criteria
- MR imaging of the liver with liver lesions suspicious for metastases
- PET computed tomography (PET/CT) with liver lesions suspicious for metastases
- Patient is eligible and designated for treatment with standard-of-care first-line bevacizumab-containing, fluoropyrimidine-based chemotherapy.
- ECOG performance status ≤ 2 (see appendix)
Exclusion Criteria:
- Inability or unwillingness to comply with the participation requirements
- History of untreated hyperthyreosis
- History of intolerance of or allergy to iodine contrast media according to CTCAE V4.03
- Calculated creatinine clearance < 45 ml/min
- For fertile women: positive urine pregnancy test or lactation.
- Known or suspected non-compliance, drug or alcohol abuse
- Life expectancy of less than 3 months
- Participation in another interventional trial with an investigational medicinal product (IMP) and within 30 days prior to screening
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Diagnóstico
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Otro: Perfusion-computed tomography (CTP)
Patients undergo a total of four perfusion-computed tomographies from baseline to progression of disease.
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Contrast-enhanced computed tomography of liver metastases
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
CTP as predictive marker for efficacy measured by progression-free survival
Periodo de tiempo: one year
|
Predictive power of decrease in tumor vasculature on the clinical outcome in bevacizumab-based chemotherapy measured by progression-free survival (PFS).
Decrease in tumor vasculature is measured by blood flow in CTP 3 compared to CTP 1 (baseline)
|
one year
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
CTP as predictive marker for efficacy measured by progression-free survival
Periodo de tiempo: one year
|
Predictive power of decrease in tumor vasculature on the clinical outcome in bevacizumab-based chemotherapy measured by progression-free survival (PFS).
Decrease in tumor vasculature is measured by blood flow, blood volume, mean transit time and permeability surface-area product in CTP
|
one year
|
CTP as predictive marker for efficacy measured by overall survival
Periodo de tiempo: four years
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Predictive power of decrease in tumor vasculature measured by CTP on the clinical outcome in bevacizumab-based chemotherapy measured by overall survival (OS)
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four years
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Tumor vasculature at progression
Periodo de tiempo: one year
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Tumor vasculature measured by blood flow, blood volume, mean transit time and permeability surface-area product in CTP at the time of confirmed progression
|
one year
|
Subgroup analyses according to the RAS mutation status, BRAF mutation status and VEGF-A level
Periodo de tiempo: one year
|
Predictive power of RAS-mutation status, BRAF-mutation status and VEGF-A level on the clinical outcome in bevacizumab-based chemotherapy measured by progression-free survival (PFS)
|
one year
|
Local and distant recurrences
Periodo de tiempo: one year
|
Rates of local and distant recurrences according to RECIST 1.1 criteria
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one year
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Patrick Veit-Haibach, MD, University Hospital Zurich, Diagnostic and Interventional Radiology
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Anticipado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- KEK-ZH-Nr. 2015-0084
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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