Tomosynthesis vs. Contrast-Enhanced Mammography in Women With Personal History of Breast Cancer in Western Pennsylvania
Palabras clave
Abstracto
Descripción
The investigators expect to show in a prospective clinical trial that, in women with a personal history of breast cancer, contrast-enhanced mammography substantially improves breast cancer detection compared to mammography with tomosynthesis, with minimal increase in false positives. The investigators expect a substantial increase in node-negative invasive cancers in particular. Because DBT will be interpreted first by one reader, and CEM will be interpreted first, and independently, by a second reader, there will also be an assessment of performance of tomosynthesis alone or CEM alone in this population.
fechas
| Verificado por última vez: | 09/30/2019 |
| Primero enviado: | 09/05/2019 |
| Inscripción estimada enviada: | 09/05/2019 |
| Publicado por primera vez: | 09/10/2019 |
| Última actualización enviada: | 10/22/2019 |
| Última actualización publicada: | 10/24/2019 |
| Fecha de inicio real del estudio: | 10/22/2019 |
| Fecha estimada de finalización primaria: | 11/30/2021 |
| Fecha estimada de finalización del estudio: | 03/27/2023 |
Condición o enfermedad
Intervención / tratamiento
Device: Contrast-enhanced mammogram
Fase
Grupos de brazos
| Brazo | Intervención / tratamiento |
|---|---|
| Experimental: Contrast-enhanced mammogram All women will receive both 3D mammography and contrast-enhanced mammography for breast cancer screening; the order of interpretation will vary for each of two radiologists | Device: Contrast-enhanced mammogram Contrast-enhanced mammography (CEM) is a new FDA-approved exam that is similar to magnetic resonance imaging (MRI) in depicting breast cancers due to increased and leaky blood vessels. Contrast-enhanced mammography is used as an adjunct following mammography and/or ultrasound examinations to localize a known or suspected lesion. |
Criterio de elegibilidad
| Edades elegibles para estudiar | 30 Years A 30 Years |
| Sexos elegibles para estudiar | Female |
| Acepta voluntarios saludables | si |
| Criterios | Inclusion Criteria: -Asymptomatic women, ages 30-85, with a personal history of breast cancer who have had at least one routine mammogram since treatment. Exclusion Criteria: - Women with a history of prior iodinated contrast reaction - Women with implant(s) in the breasts to be screened (as this creates artifacts and diagnostic performance of imaging in women with implants likely does not generalize to those without implants, and the sample size with implants would be too small to infer conclusions) - Women who have had bilateral mastectomy - Women with a history of kidney failure or estimated glomerular filtration rate (eGFR) < 60 mL/min - Pregnancy or lactation - Contraindication to magnetic resonance imaging (MRI) (if needed for biopsy guidance): Pacemaker, metallic implant near vital structure, history of reaction to gadolinium-based contrast; body habitus (typically weight > 300 lbs) incompatible with scanner; hardware that would cause artifacts in the breasts (e.g. spinal fixation rods) - Severe claustrophobia - Women actively being treated for cancer of any type with chemotherapy. |
Salir
Medidas de resultado primarias
1. Cancer Detection [18 months]
Medidas de resultado secundarias
1. Reader Validation [24 months]
