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The Role of Gadoxetate Enhanced Spectral Dual-Energy CT in Evaluating Hilar Cholangiocarcinoma

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Qué se está evaluando

CT scan

Medicamento
Quiénes están siendo reclutados

Adenocarcinoma+2

+ Carcinoma

+ Neoplasias

A partir de 19 años
+8 Criterios de eligibilidad
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Cómo está diseñado el estudio

Estudio de Tratamiento

Fase Temprana 1
Intervencional
Inicio del estudio: agosto de 2012
Ver detalles del protocolo

Resumen

Patrocinador PrincipalUniversity of Alabama at Birmingham
Última actualización: 1 de junio de 2017
Extraido de una base de datos validada por el gobierno.Reclamar como socio

Fecha de inicio: 1 de agosto de 2012

Fecha en la que se inscribió al primer participante.

The purpose of this project is to evaluate the role of gadoxetate (Eovist) enhanced dual-energy CT in better evaluating perihilar cholangiocarcinoma, by exploiting the combination of the physiologic behavior of gadoxetate in liver tissue combined with the advantageous mass attenuation coefficient of Gadolinium achievable through dual energy technique. This combination of unique CT imaging sensitivity, high resolution and differential enhancement potentially allows improved visualization and detection of tumor relative to enhancing surrounding hepatic parenchyma and ductal anatomy in the hepatobiliary phase, due to the biliary excretion of the agent. Cholangiocarcinoma is a hepatic adenocarcinoma that arises from the bile duct epithelium and is the second most prevalent liver cancer after hepatocellular carcinoma. The hilar intrahepatic variety of cholangiocarcinoma can present as an infiltrative, exophytic, or polypoid lesion. Most extra-hepatic cholangiocarcinomas are infiltrative, causing a focal stricture of the bile duct and result in proximal biliary ductal dilatation. While magnetic resonance (MR) cholangiography is diagnostic in the majority of patients with malignant hilar strictures, evaluation is limited by spatial resolution and in some patients, the inability to have an MRI scan. Standard Multi Detector CT (MDCT) using iodinated contrast agents, on the other hand, is limited in evaluation of cholangiocarcinomas, due to the lack of consistent enhancement of the tumor with iodinated contrast. Single-source, Dual-Energy (SSDE) Spectral MDCT utilizes a single fast switching x-ray beam source to acquire near simultaneous data sets at two different photon energies during a single acquisition. Data is acquired at 80 kilovolt peak (kVp) and 140 kVp with image reconstruction achievable as a selectable monochromatic presentation over a range of 40 - 140 kiloelectron volt (keV), typically 70-78 keV for diagnostic image presentation. At lower tube voltage, the frequency of photoelectric interactions increases exponentially and is strongly dependent on the atomic number. Therefore, for substances with higher atomic number, such as iodine and gadolinium the increased frequency of photoelectric and k-edge interactions at low tube voltage substantially increases CT attenuation, thus improving contrast. Gadolinium is further unique with k-edge attenuation at approximately 53 keV, within the available monochromatic reconstruction range, thus allowing for significant greater detectability. Additional material decomposition technique allows for unique material presentation and analysis such as gadolinium/ water pair analysis with high spatial resolution. Dual-Energy technology is limited by the types of contrast agents currently available, all based on Iodine. Gadoxetate (Eovist) is a relatively new Gadolinium based MRI contrast agent that is capable of producing not only standard appearing MRI images in the hepatic arterial and portal venous phases, but also provides an opportunity to better visualize the bile ducts and liver parenchyma as it is excreted by the liver into the biliary system during the hepatobiliary phase. This pilot project aims to address a long-term pitfall in the imaging of cholangiocarcinomas, by providing higher resolution delineation of these often infiltrative tumors on single-source, Dual-Energy Spectral MDCT, capitalizing on improved spatial resolution achievable with MDCT compared to MRI and at the same time producing a non-invasive CT cholangiogram to aid in accurate diagnosis and treatment planning of cholangiocarcinoma, particularly, the hilar variety.

Patrocinador PrincipalUniversity of Alabama at Birmingham
Última actualización: 1 de junio de 2017
Extraido de una base de datos validada por el gobierno.Reclamar como socio

Protocolo

Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.
Detalles del Diseño

Se reclutarán 18 pacientes

Número total de participantes que el ensayo clínico espera reclutar.

Estudio de Tratamiento

Estos estudios prueban nuevas formas de tratar una enfermedad, condición o problema de salud. El objetivo es determinar si un nuevo medicamento, terapia o enfoque funciona mejor o tiene menos efectos secundarios que las opciones existentes.



Elegibilidad

Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.
Condiciones
Criterios

Cualquier sexo

Sexo biológico de los participantes elegibles para inscribirse.

A partir de 19 años

Rango de edades de los participantes que pueden unirse al estudio.

Voluntarios sanos no permitidos

Indica si personas sanas, sin la condición que se estudia, pueden participar.

Condiciones

Patología

AdenocarcinomaCarcinomaNeoplasiasNeoplasias por tipo histológicoNeoplasias glandulares y epiteliales

Criterios

3 criterios de inclusión requeridos para participar
Subject must be able to provide a written informed consent

Subject will be scheduled for gadoxetate contrast enhanced MRI scan of the liver (obtained as part of usual clinical practice)

Subjects will be adult (age 19 or older) with suspected cholangiocarcinoma of the liver

5 criterios de exclusión impiden participar
Standard MRI safety screening criteria will be employed, and subject will be excluded if any contraindications to undergo MRI are met

Subject may not be pregnant or lactating

Subjects on hemodialysis or with glomerular filtration rate (GFR) less than 30 will be excluded

Subjects will not be excluded on the basis of gender, race, ethnicity, or religion

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Plan de Estudio

Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.
Grupos de Tratamiento
Objetivos del Estudio

Un solo grupo de intervención está designado en este estudio

0% de probabilidad de ser asignado al grupo placebo

Grupos de Tratamiento

Grupo I

Experimental
Patients will undergo a standard of care Gadoxetate (Eovist) MRI for cholangiocarcinoma. Patients will then be immediately placed on the CT scanner. Patients will undergo a dual energy CT of the abdomen with no additional contrast.

Objetivos del Estudio

Objetivos Primarios

Centros del Estudio

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Este estudio tiene una ubicación

University of Alabama at Birmingham

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Completado1 Centros de Estudio