- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01524029
Digital Breast Tomosynthesis Versus Digital Mammography: A National Multicenter Trial
Digital Breast Tomosynthesis vs. Digital Mammography: A National Multicenter Trial
The goal of this study is to determine the value of the new mammography technique called Digital Breast Tomosynthesis (DBT) compared to the current standard technique Digital Mammography for the early detection of Breast Cancer.
DBT is able to compute a three-dimensional image of a breast from several low-dose mammographies taken from different angles while the device is moving around the breast in a circular motion. This should overcome a significant limitation of Digital Mammography arising from the masking of breast cancer in a mammography image caused by overlying normal breast tissue.
This is a study conducted in several Austrian Breast Imaging Centers.
Descripción general del estudio
Estado
Condiciones
Descripción detallada
This prospective national multicenter multivendor trial aims at determining the impact of the novel technique Digital Breast Tomosynthesis (DBT) in the assessment and screening for breast cancer. Mammography is the primary imaging modality for the early detection of clinically occult breast cancer.
Despite advances in mammographic technique, mammography is still limited with regard to both sensitivity and specificity. In the majority of cases these limitations arise from the masking of subtle breast cancer lesions by overlapping breast tissue.
DBT is a novel technique that tries to overcome these limitations by performing a 3D-reconstruction of breast tissue from multiple low-dose digital mammographic images acquired in several planes in a 15 to 50 degree angle.
Early studies indicate an advantage of DBT compared to the standard Full Field Digital Mammography (FFDM) in terms of an improvement of specificity without cutback in sensitivity.
Controversy continues over the use of DBT in combination with FFDM or as a standalone screening method without concomitant 2D imaging. Unfortunately, the peer-reviewed publications evaluating DBT are limited and consist of single institution studies with a small number of participants.
The purpose of this study is to evaluate the novel technique of DBT compared to routine FFDM in a clinical large sample study (600 participants) to provide the path to implementation of this new technique into clinical and screening routine.
Tipo de estudio
Inscripción (Anticipado)
Contactos y Ubicaciones
Ubicaciones de estudio
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Vienna, Austria, A-1090
- Reclutamiento
- Medical University of Vienna
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Contacto:
- Thomas Moritz, MD
- Número de teléfono: 4818 +43140400
- Correo electrónico: thomas.moritz@meduniwien.ac.at
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Vienna, Austria, A-1100
- Reclutamiento
- Kaiser Franz Josef Spital
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Contacto:
- Gabrielle Kienzer, MD
- Número de teléfono: 3608 +43160191
- Correo electrónico: Gabrielle.kienzer@wienkav.at
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Vienna, Austria, A-1140
- Reclutamiento
- Hanusch Krankenhaus
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Contacto:
- Reinhard Bernt, MD
- Número de teléfono: 86630 +43191021
- Correo electrónico: reinhard.bernt@wgkk.at
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Styria
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Graz, Styria, Austria, A-8036
- Reclutamiento
- Medical University of Graz
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Contacto:
- Sabine Oswald, MD
- Número de teléfono: 13850 +43 316385
- Correo electrónico: sabine.oswald@klinikum-graz.at
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Upper Austria
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Wels, Upper Austria, Austria, A-4600
- Reclutamiento
- Klinikum Wels-Grieskirchen
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Contacto:
- Stefan Meindl, MD
- Número de teléfono: 2413 +437242415
- Correo electrónico: stefan.meindl@klinikum-wegr.at
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
The study population consists of two groups:
One screening group consisting of asymptomatic women (Age 40+) referred for a screening mammography examination.
The second group consists of women aged 25+ referred for further examination of a breast lesion.
Descripción
Inclusion Criteria:
- Age > 25 years (40 years or older for Screening Cohort)
- No history of breast cancer
- Written informed consent
- Asymptomatic women in follow up for early detection of breast cancer or
- Patients with a recent positive mammography (BI-RADS 3-5)
Exclusion Criteria:
- Pregnant and breast feeding women
- Unable to tolerate breast compression
- Breast implants
- Unable to understand or execute written informed consent
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
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Breast Cancer Screening Patients
Group 1 consists of Women referred to Breast Cancer Screening examinations at a participating Austrian Breast Imaging Site
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Diagnostic Patients
Patients referred to a participating Breast Imaging Center for a clinically or radiologically detected breast lesion
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
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Specificity of Digital Breast Tomosynthesis in the characterization of Breast lesions
Periodo de tiempo: One year
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One year
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
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Sensitivity of Digital Breast Tomosynthesis in the detection of malignant breast lesions
Periodo de tiempo: One year
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One year
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Thomas Moritz, MD, Medical University of Vienna
- Director de estudio: Thomas Helbich, MD Prof. MBA MSc, Medical University of Vienna
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
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 (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
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- TomoTrial001
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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