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Comparison Study of Breast Tomosynthesis Slice Thicknesses

19 de noviembre de 2013 actualizado por: Mary Newell, MD, Emory University

A Comparison Study of Breast Tomosynthesis Images Reconstructed at 1 Millimeter and 5 Millimeter Slice Thicknesses

Early diagnosis is one of the most important factors in the survival of patients diagnosed with breast cancer. To aid in the early detection of breast cancer, a new technology, called tomosynthesis imaging is being developed. The idea behind tomosynthesis imaging is to "look" at the breast from different points of view by obtaining x-ray flat images from different angles while the breast does not move, and then mathematically combine these flat images into a three-dimensional image. The benefit of these three dimensional images is that the radiologist can look at the different tissues of the breast in their real positions, as opposed to all the tissues being "flattened" into a flat image, like that of a normal mammogram. Since tomosynthesis images of the breast show the tissues in their real position, the radiologist should be able to more easily find a tumor and also be able to reduce the number of time he or she thinks there is a tumor present when in reality there is not one there.

Before this new technology can be used in the clinic routinely, it is necessary to perform a large number of studies to find the optimal way to use it. In this study, the investigators are aiming to find how thick the slices or layers representing the breast should be in the image when shown to the radiologist. The difference between these two thicknesses in how useful the images are to the radiologist could be important. The investigators are trying to determine if slicing the image of the breast into thicker slices will make the job of the radiologist easier or not when deciding to recommend or not a biopsy (laboratory analysis) of what the previous mammogram found. To find the answer to this question, the investigators will image patients with their tomosynthesis machine and look at the tomosynthesis images with the thin and thick slices. The radiologists that read each image will decide if they would have recommended the patient to get a biopsy based only in each of these images. The recommendations based on the images with thin slices and the recommendations based on the images with thick slices will be compared with what was actually recommended using the standard clinical tests. The investigators hope to find that the thicker slices help more than the thinner slices when trying to decide if biopsy is needed or not.

Descripción general del estudio

Estado

Terminado

Condiciones

Descripción detallada

Early diagnosis is one of the most important factors in the survival of patients diagnosed with breast cancer. To aid in the early detection of breast cancer, a new technology, called tomosynthesis imaging is being developed. The idea behind tomosynthesis imaging is to "look" at the breast from different points of view by obtaining x-ray flat images from different angles while the breast does not move, and then mathematically combine these flat images into a three-dimensional image. The benefit of these three dimensional images is that the radiologist can look at the different tissues of the breast in their real positions, as opposed to all the tissues being "flattened" into a flat image, like that of a normal mammogram. The flat images in mammograms bring about the possibility that normal healthy tissue sometimes covers up malignant tumors, making them harder, and sometimes impossible, for the physician to see. In addition, this "flattening" sometimes generates what appears to be suspicious tissue, but is in reality a superposition of normal healthy tissue. This effect results in performing an increased number of biopsies that end up being negative for breast cancer. Since tomosynthesis images of the breast show the tissues in their real position, these effects can be avoided. It has already been shown by various research labs, including ours, that this kind of imaging does in fact result in better visualization of lesions compared to conventional two-dimensional imaging, even without performing tomosynthesis under ideal conditions.

For tomosynthesis to reach its full potential, it is necessary to perform a large number of studies to find the optimal way to acquire the tomosynthesis images and the optimal way to mathematically combine these images to get the three dimensional image. In this study, we are aiming to find if the resulting three dimensional image should be divided into slices or layers each representing 1 millimeter (less than one 16th of an inch) of the breast or 5 millimeters (one 5th of an inch) of the breast. The difference between these two thicknesses in how useful the images are to the radiologist could be important. Up to now, tomosynthesis imaging has been performed with 1 millimeter slices, but there has been no scientific study to prove that this is the best slice thickness. We will try to determine if slicing the image of the breast into thicker slices will make the job of the radiologist easier or not when deciding to recommend or not a biopsy (laboratory analysis) of what the previous mammogram found. To find the answer to this question, we will image patients with our tomosynthesis machine and look at the tomosynthesis images with the thin and thick slices. The radiologists that read each image will decide if they would have recommended the patient to get a biopsy based only in each of these images. The recommendations based on the images with thin slices and the recommendations based on the images with thick slices will be compared with what was actually recommended using the standard clinical tests. We hope to show that the images with the thick slices will do as well if not better than those with the thin slices. Even if the thick slices only do as well as the thin slices, this will show that creating images with thicker slices is better, since these images can be read faster by the radiologist.

Tipo de estudio

De observación

Inscripción (Actual)

182

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

    • Georgia
      • Atlanta, Georgia, Estados Unidos, 30322
        • Emory University Hospital Breast Imaging Center

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

35 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

Sí

Géneros elegibles para el estudio

Femenino

Método de muestreo

Muestra no probabilística

Población de estudio

The target population for this study is women who are recalled for an abnormal finding on a screening mammogram.

Descripción

3.1 Eligibility Criteria All subjects will be women at least 35 years of age that have been found, after diagnostic workup, to have focal distributions of microcalcifications (BI-RADS 3, 4 or 5), focal soft tissue lesions (BI-RADS 3, 4 or 5), or no findings (BI-RADS 1).

3.2 Ineligibility Criteria

  • Subject does not meet any of the inclusion criteria
  • Women with suspected or confirmed pregnancy
  • Women who have had bilateral mastectomy
  • Women with large breasts that cannot be accommodated within the field of view of the tomosynthesis system
  • Women who are very frail and unable to cooperate
  • Women who are under 35 years of age
  • Women who cannot give informed consent
  • Male subjects
  • Women with implants
  • Subject has had breast augmentation, except for unilateral augmentation done for prior mastectomy

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Periodo de tiempo
Equivalence in diagnostic accuracy
Periodo de tiempo: After biopsy or follow-up
After biopsy or follow-up

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Colaboradores

Investigadores

  • Investigador principal: Mary Newell, MD, Emory University

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

1 de abril de 2009

Finalización primaria (Actual)

1 de septiembre de 2011

Finalización del estudio (Actual)

1 de diciembre de 2012

Fechas de registro del estudio

Enviado por primera vez

11 de agosto de 2009

Primero enviado que cumplió con los criterios de control de calidad

11 de agosto de 2009

Publicado por primera vez (Estimar)

12 de agosto de 2009

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

21 de noviembre de 2013

Última actualización enviada que cumplió con los criterios de control de calidad

19 de noviembre de 2013

Última verificación

1 de noviembre de 2013

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • IRB00008667

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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