- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01395030
PET/CT in Diagnosing Patients With Liver Cancer Undergoing Surgical Resection
Genomic and Imaging Study for Patients Undergoing Surgery for Liver Cancer
Descripción general del estudio
Estado
Descripción detallada
PRIMARY OBJECTIVES:
I. Determine the most optimal fluorine-18 (18F) fluoromethylcholine (FCH) PET/CT parameters for detecting primary hepatocellular carcinoma (HCC) by conducting a clinical radiologic-pathologic correlation study to estimate and compare the receiver operating characteristics of kinetic and static PET measures of tumor FCH metabolism in patients that test positive during screening or conventional imaging.
II. Identify cancer signaling pathways associated with choline metabolism in HCC by profiling the global gene expression patterns in fresh-frozen liver tissue samples that are correlated with the features derived from FCH PET/CT images.
III. Characterize the association between features derived from FCH PET/CT images of the liver and clinical liver disease severity and comparatively evaluate the ability of corresponding gene expression signatures to predictively model HCC disease outcome.
OUTLINE:
Patients undergo 18F-fluoromethylcholine PET/CT within 14 days of surgical resection.
After completion of study treatment, patients are followed up periodically.
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 2
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Hawaii
-
Honolulu, Hawaii, Estados Unidos, 96813
- University of Hawaii Cancer Center
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Liver tumor diagnosed histologically as HCC or suspected of being HCC in association with serum alpha-fetoprotein level > 200 or tumor mass with characteristics of malignancy on diagnostic imaging
- Under the care of a surgical attending
- Deemed a surgical candidate and has agreed to surgery to remove a portion of the liver containing tumor
- Child-Pugh A/B
Exclusion Criteria:
- Weight > 350 lbs
- Pregnant or lactating female, a serum pregnancy test will be performed within 2 weeks or less before the date of the FCH PET/CT scan in all women capable of becoming pregnant
- Serious underlying medical condition that would impair patient's ability to tolerate the imaging procedure
- Concurrent treatment with chemotherapy, molecule-selective, biological, or radiotherapeutic agent
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: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: 18F-fluoromethylcholine PET/CT
Patients undergo 18F-fluoromethylcholine positron emission tomography (PET)/ computed tomography (CT) scan within 14 days of surgical resection of liver tumor.
|
Undergo FCH PET/CT
Otros nombres:
Undergo FCH PET/CT
Otros nombres:
Undergo FCH PET/CT
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Fluorine-18 (18F) Fluoromethylcholine (FCH) PET/CT Parameters for Assessing Hepatocellular Carcinoma (HCC): Area Under the Receiver Operating Characteristic Curve.
Periodo de tiempo: Up to study completion at an average of 2.5 years
|
Area under the receiver operating characteristic curve for detecting resectable hepatocellular carcinoma with prognostically favorable molecular features (Hoshida molecular sub-class S3) based on FCH PET/CT measurement of tumor maximum standardized uptake value (SUVmax).
|
Up to study completion at an average of 2.5 years
|
Fluorine-18 (18F) Fluoromethylcholine (FCH) PET/CT Parameters for Assessing Hepatocellular Carcinoma (HCC): Sensitivity/Specificity
Periodo de tiempo: Up to study completion at an average of 2.5 years
|
Sensitivity and specificity estimated at a predefined point (ie.
Youden's maxima) on the receiver operating characteristic curve for detecting hepatocellular carcinoma with prognostically favorable molecular features (Hoshida molecular sub-class S3) based on FCH PET/CT measurement of tumor maximum standardized uptake value (SUVmax) in patients who underwent subsequent tumor resection.
|
Up to study completion at an average of 2.5 years
|
Statistical Significance of Molecular Pathways Associated With Choline Metabolism as Identified Through Gene Set Enrichment Analysis of Hepatocellular Carcinoma (HCC) Tumor Samples.
Periodo de tiempo: Up to study completion at an average of 2.5 years
|
Statistically significant enrichment by sets of genes corresponding to previously-defined molecular pathway signatures was assessed by gene set enrichment analysis (a publicly available algorithm) of whole-genome expression array data obtained from tumors previously characterized by FCH PET/CT.
Statistical significance was based on a false discovery rate < 0.05.
Tumors demonstrating high choline metabolism (defined by a tumor-liver ratio > 1.0 measured on PET) were assessed for enrichment by publicly-available gene sets.
This particular analysis involved the entire Molecular Hallmarks gene signature collection (v6.0) as obtained from the Broad Institute Molecular Signature Database (MSigDB).
|
Up to study completion at an average of 2.5 years
|
Clinical Liver Disease Severity Based on Liver Fibrosis (Metavir) Stage
Periodo de tiempo: Up to 1 year
|
Odds ratios and 95% confidence intervals for histologic liver fibrosis (Metavir) stage >= F1, >= F2, >= F3, and F4 at liver standardized uptake value (SUV) thresholds of 8.3, 8.0, 7.4, and 6.4, respectively.
Reference: PMID 29315063.
|
Up to 1 year
|
Number of Participants Comprising Two Distinct PET/CT Imaging Phenotypes (High FCH Uptake vs. Low FCH Uptake) Between the Different Tumor Sub-classes
Periodo de tiempo: Up to study completion at an average of 2.5 years
|
HCC tumors were sub-classified using gene expression arrays into 3 distinct prognostically-relevant molecular sub-classes (S1,S2, S3, where S3 is associated with the most favorable clinical prognosis) based on Hoshida et.
al (PMID 19723656).
The number of tumors comprising two distinct PET/CT imaging phenotypes (high FCH uptake vs. low FCH uptake) was compared between the different sub-classes.
|
Up to study completion at an average of 2.5 years
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Sandi Kwee, MD, Queen's Medical Center
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
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 (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Enfermedades del Sistema Digestivo
- Neoplasias por tipo histológico
- Neoplasias
- Neoplasias por sitio
- Adenocarcinoma
- Neoplasias Glandulares y Epiteliales
- Neoplasias del Sistema Digestivo
- Enfermedades del HIGADO
- Carcinoma
- Carcinoma Hepatocelular
- Neoplasias Hepaticas
- Mecanismos moleculares de acción farmacológica
- Antimetabolitos
- Agentes Gastrointestinales
- Agentes hipolipidémicos
- Agentes reguladores de lípidos
- Agentes nootrópicos
- Agentes lipotrópicos
- Colina
Otros números de identificación del estudio
- RA-2011-025 (Otro identificador: Queen's Medical Center)
- NCI-2012-02095 (Identificador de registro: CTRP (Clinical Trial Reporting Program))
- CHS-19373 (Otro identificador: University of Hawaii)
- R01CA161209 (Subvención/contrato del NIH 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. .