Koning Breast CT for Breast Imaging in China
Contrast-enhanced KBCT
Enfermedades de la Mama+2
+ Neoplasias
+ Neoplasias por Sitio
Estudio Diagnóstico
Resumen
Fecha de inicio: 1 de mayo de 2012
Fecha en la que se inscribió al primer participante.This study is conducted to compare Koning Breast CT (KBCT) to mammography to evaluate if KBCT can improve the diagnostic accuracy of breast cancer. It will also compare contrast-enhanced KBCT (CE-KBCT) to mammography to evaluate if CE-KBCT can further improve the diagnostic accuracy of breast cancer.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 418 pacientes
Número total de participantes que el ensayo clínico espera reclutar.Estudio Diagnóstico
Elegibilidad
Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.Mujer
Sexo biológico de los participantes elegibles para inscribirse.A partir de 35 años
Rango de edades de los participantes que pueden unirse al estudio.Voluntarios sanos permitidos
Indica si personas sanas, sin la condición que se estudia, pueden participar.Condiciones
Patología
Criterios
Non-contrast KBCT Inclusion Criteria: Females at least 35 years of age of any ethnicity Had diagnostic imaging Will undergo study imaging no later than two weeks from date of diagnostic mammogram Is able to undergo informed consent Exclusion Criteria: Pregnancy Lactation Subjects with physical limitations that may prohibit resting prone on the exam table, such as, but not limited to: frozen shoulder, recent heart surgery, pace maker. Subjects who are unable to tolerate study constraints. Subjects who have received radiation treatments to the thorax for malignant and nonmalignant conditions, such as (but not limited to) Treatment for enlarged thymus gland as an infant Irradiation for benign breast conditions, including breast inflammation after giving birth Treatment for Hodgkins disease Subjects who have participated in a prior breast clinical trial that gave additional radiation dose, such as an additional mammogram. Subjects who have received large numbers of diagnostic x-ray examinations for monitoring of disease such as (but not limited to) Tuberculosis Severe scoliosis Contrast-enhanced KBCT Inclusion Criteria: Females at least 35 years of age of any ethnicity Had diagnostic imaging and was determined to have biopsy or surgery Will undergo study imaging no later than two weeks from date of diagnostic mammogram Is able to undergo informed consent Exclusion Criteria: Same as the exclusion criteria as non-contrast KBCT, plus the following: Abnormal Glomerular Filtration Rate (GFR)/Blood Urea Nitrogen (BUN) or Creatinine at Pre contrast blood screening Previous non-ionic contrast reaction History of renal dysfunction/kidney disease Diabetes mellitus treated with metformin Multiple myeloma Dehydration History of nephrotoxic medication use Hyperthyroidism Pheochromocytoma Sickle Cell Disease
Plan de Estudio
Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.2 grupos de intervención están designados en este estudio
0% de probabilidad de ser asignado al grupo placebo
Grupos de Tratamiento
Grupo I
Sin IntervenciónGrupo II
ExperimentalObjetivos del Estudio
Objetivos Primarios
Objetivos Secundarios
Centros del Estudio
Estos son los hospitales, clínicas o centros de investigación donde se lleva a cabo el estudio. Puedes encontrar la ubicación más cercana a ti y su estado de reclutamiento.Este estudio tiene 2 ubicaciones
Sun Yat-Sen University Cancer Center
Guangzhou, ChinaAbrir Sun Yat-Sen University Cancer Center en Google MapsTianjin Medical University Cancer Institute and Hospital
Tianjin, China