- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT03889093
Radioembolization of Primary and Secondary Liver Malignancies and The Effect On The Immune System
Radioembolization of Primary and Secondary Liver Malignancies and The Effect On The Immune System: A Prospective Study of Cytokine Modulation And Immune Cell Infiltration
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
This is a single institution non-interventional study designed to evaluate the immune reaction to radioembolization (RE) of primary and secondary malignancies of the liver.
RE has been established as a standard of care treatment for both primary and secondary cancers of the liver. The treatment consists of a mapping, or planning angiogram, followed by a delivery angiogram where the dose of yttrium 90 (y90) is delivered. Data has been published on the immune modification powers of external beam radiation (XRT). However, very little data is available on the ways in which RE modifies the immune system. The goal of this study is to determine changes in the peripheral blood monocytes, cytokines and the treated and untreated liver tumors through sample collection prior to and for 12 weeks after standard of care RE.
The prior to, the RE delivery procedure patients will have a blood draw to evaluate for levels of 11 immunologically relevant cytokines (IL-1α, IL-1β, IL-2, IL-6, IL-10, IL-12p70, IL-18, TNFα, IFN-ϒ, Fit ligand 3, and MCP-1). These blood draws will be repeated at 7 days (- 2 days, + 5 days), 4 weeks (± 2 weeks) and 12 weeks (± 2 weeks) after RE.
The patients will also have the infiltration of immune relative cells into treated tumors evaluated. This will be done by the patients undergoing biopsy of the largest tumor to be treated prior to treatment and at 2 weeks (±7 days) following RE. If patients have other areas of tumor, which are not included in the initial treatment site, these areas will also be biopsied.
Finally, the change in immunologically important peripheral lymphocytes will be collected. This will be done with a blood draw on the day of, but prior to RE serving as an internal control. Patients will then also have blood draws performed at 7 days (±2 days), 4 weeks (± 2 weeks) and 12 weeks (± 2 weeks) after RE.
Tipo de estudio
Inscripción (Anticipado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Shamar J Young, MD
- Número de teléfono: 612-626-5566
- Correo electrónico: youn1862@umn.edu
Ubicaciones de estudio
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Minnesota
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Minneapolis, Minnesota, Estados Unidos, 55455
- Reclutamiento
- University of Minnesota
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Contacto:
- Shamar J Young, MD
- Número de teléfono: 612-626-5566
- Correo electrónico: youn1862@umn.edu
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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:
- Biopsy or image (in the setting of hepatocellular carcinoma (HCC)) diagnosed hepatic malignancy
- Total bilirubin < 2 mg/dL
- ECOG status ≤ 2
- Life expectancy >3 months as documented in the medical record by the enrolling physician
- Age >22 years
- Lesion >2.0 cm which is amenable to percutaneously biopsied
Exclusion Criteria:
- Unwilling or unable to attend all study related follow ups
- Technetium 99 macro aggregated albumin (MAA) lung shunt fraction >20%
- Arterial anatomy which precludes the ability to safely perform RE
- INR > 1.8 or platelet count <50,000 which cannot be corrected
- Patients who are unable to hold anticoagulation and/or antiplatelet therapy in the periprocedural setting
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- 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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Otro: Yttrium-90
This single arm study is to evaluate immunologic changes following the treatment of primary or secondary malignancies of the liver utilizing beta-emitting, Yttrium-90.
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This is to evaluate the immunologic effects of yttrium 90.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Change in concentrations of PBMC
Periodo de tiempo: 12 weeks
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Determine changes in the peripheral blood lymphocytes utilizing flow cytometery after radioembolization (RE) therapy for primary and secondary malignancies of the liver at 12 weeks.
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12 weeks
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Change in concentrations of cytokines
Periodo de tiempo: 1, 4, 12 weeks
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Determine changes in the peripheral blood cytokines after radioembolization (RE) therapy for primary and secondary malignancies of the liver.
Specifically cytokines IL-1α units/mg, IL-1β units/mg, IL-2 units/mg, IL-6 units/mg, IL-10 units/mg, IL-12p70 units/mg, IL-18 units/mg, TNFα units/mg, IFN-Y units/mg, Fit ligand 3 units/mg, and MCP-1 units/mg will be measured.
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1, 4, 12 weeks
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Change in concentrations of immune cell infiltration into the tumor
Periodo de tiempo: 1, 4, 12 weeks
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Determine the changes in infiltrating immune cells within the treated tumor, which occur after radioembolization (RE) therapy for primary and secondary malignancies of the liver.
This will be accomplished by obtaining tissue samples of the treated tumor before and after treatment, then performing staining and cell counts to determine the change in cytotoxic t cells, t helper cells, natural kill cells, macrophages, and dendritic cells.
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1, 4, 12 weeks
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Change in concentrations of PBMC
Periodo de tiempo: 1 and 4 weeks
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Determine changes in the peripheral blood lymphocytes utilizing flow cytometery after radioembolization (RE) therapy for primary and secondary malignancies of the liver at 1 and 4 weeks.
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1 and 4 weeks
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Shamar J Young, Young, University of Minnesota
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Anticipado)
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 (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
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
- 2018LS026
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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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