Pilot Study: High Risk Breast Cancer Screening Pilot Study
motexafin gadolinium
+ biopsy
+ breast imaging study
Enfermedades de la Mama+2
+ Neoplasias
+ Neoplasias por Sitio
Estudio de Detección
Resumen
Fecha de inicio: 1 de junio de 1999
Fecha en la que se inscribió al primer participante.OBJECTIVES: Estimate the diagnostic yield and positive predictive value of breast magnetic resonance imaging (MRI) for the detection of cancer in women who are at greater than 25% lifetime risk for developing breast cancer. Compare the diagnostic yield and positive predictive value of MRI with conventional breast cancer screening (mammography and physical examination) for the detection of breast cancer in women with a greater than 25% lifetime risk of developing breast cancer. OUTLINE: All patients receive a physical exam within 90 days of initial MRI scan. Patients undergo a two view screening mammogram within 3 months prior to study entry. Patients undergo an MRI with gadolinium contrast at entry. All lesions identified as suspicious on physical examination, mammography, or MRI undergo a core needle or excisional biopsy. PROJECTED ACCRUAL: A total of 200 patients will be accrued for this study within 2 years.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 200 pacientes
Número total de participantes que el ensayo clínico espera reclutar.Estudio de Detección
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.De 25 a 120 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
Criterios
DISEASE CHARACTERISTICS: Patients at greater than 25% lifetime risk for breast cancer on the basis of family history or a genetic test Prior breast cancer allowed if patient meets the greater than 25% lifetime risk Patients with greater than 5 years since diagnosis must have at least 50% probability for developing breast cancer by the Couch model or be positive for BRCA1 or BRCA2 mutation Hormone receptor status: Not specified PATIENT CHARACTERISTICS: Age: 25 and over Sex: Female Menopausal status: Not specified Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: No contraindications to MRI scan including patients with pacemakers, magnetic aneurysm clips or other implanted magnetic devices, or severe claustrophobia Not pregnant PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy Not specified Endocrine therapy Not specified Radiotherapy Not specified Surgery Not specified
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 12 ubicaciones
UCSF Cancer Center and Cancer Research Institute
San Francisco, United StatesAbrir UCSF Cancer Center and Cancer Research Institute en Google MapsUniversity of Colorado Cancer Center
Denver, United StatesPorter Adventist Hospital
Denver, United StatesHartford Hospital
Hartford, United States