Estudio abierto, multicéntrico, de fase 3, con lectura de imágenes ciega correspondiente, para determinar la eficacia y seguridad de una inyección intravenosa única de 0,1 mmol/kg de peso corporal de gadobutrol 1,0 molar (Gadovist®) en pacientes con cáncer de mama de diagnóstico reciente derivadas para resonancia magnética mamaria con contraste

CompletadoFase 3ClinicalTrials.gov

ID: NCT01067976Tipo: INTERVENTIONALInicio: 1 de feb de 2010Fin estimado: 1 de ene de 2012

Resumen

El propósito de este estudio es evaluar la eficacia (cómo funciona) y la seguridad de gadobutrol cuando se utiliza para obtener imágenes por resonancia magnética de ambas mamas. Las mujeres con un diagnóstico reciente de cáncer de mama por mamografía (examen radiológico de las mamas) pueden beneficiarse de la resonancia magnética mamaria, ya que la resonancia magnética puede detectar cánceres de mama adicionales.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Recent histologically proven diagnosis of breast cancer after having obtained X-Ray Mammography (XRM) of both breasts (according to American College of Radiology \[ACR\] and performed no longer than 6 weeks prior to enrollment into the study) and has been referred for a contrast-enhanced Magnetic Resonance Mammography (MRM) prior to surgery of the breast.
If female, a digital XRM is required if any of the following criteria is met:
patient is younger than 50 years;
patient has heterogeneously or extremely dense breasts;
is not post-menopausal (post-menopause defined as at least 12 months prior to inclusion without menstruation).
If female of childbearing potential, MRM should be performed on the 7-14th day of the menstrual cycle.
Has an estimated glomerular filtration rate (eGFR) value \>/= 60 mL/min/1.73m\^2 derived from a serum creatinine result within 2 weeks prior to study enrollment.

Criterios de exclusión

Is a female patient who is pregnant or lactating
Has any contraindication to the MRM examination (e.g. metal implants, phobia) or the use of gadolinium-containing contrast agents.
Has received any contrast agent within 24 hours prior to the study MRM, or is scheduled to receive any contrast agent within 24 hours after the study MRM.
Has severe cardiovascular disease (e.g., known long QT syndrome, acute myocardial infarction \[\< 14 days\], unstable angina, congestive heart failure New York Heart Association class IV) or acute stroke (\< 48 hours)).
Has acute renal insufficiency of any severity due to hepato-renal syndrome or in the peri-operative liver transplantation period or who has acute or chronic moderate or severe renal insufficiency (glomerular filtration rate \< 60 mL/min/1.73m\^2).
Has received chemotherapy or hormonal therapy for breast cancer within 6 months.
Has received hormone replacement therapy within 4 weeks prior to study drug administration.
Is scheduled or likely to require a surgery and/or biopsy in the time period up to 24 hours following study drug application
Has prior excisional biopsy or breast surgery less than 6 months before enrollment and between XRM and study MRM

Intervenciones

drug

Gadobutrol (Gadavist, Gadovist, BAY86-4875)

A single bolus injection of gadobutrol 1.0 M 0.1mmol/kg body weight

Ubicaciones

Buenos Aires, Ciudad Auton. de Buenos Aires, Argentina

Patrocinadores

PrincipalBayer

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