An NCI-Sponsored Exploratory Study For Determining Optimum Timing For The Imaging Of Intravenous Superparamagnetic Particle Ferumoxytol (Code7228) For The Differentiation of Metastatic and Non Metastatic Lymph Nodes in Patients With Known Primary Cancer Scheduled For Possible Surgical Lymph Node Biopsy/Dissection
Colección de datos
Enfermedades Urogenitales+9
+ Enfermedades de la Mama
+ Neoplasias de la Mama
Resumen
Fecha de inicio: 1 de septiembre de 2004
Fecha en la que se inscribió al primer participante.OBJECTIVES: Primary * Determine the range of optimal timing for magnetic resonance imaging of lymph nodes after administration of ferumoxytol, in terms of assessing signal intensity using pre-defined pulse sequences in regions of interest and visual criteria, in patients with primary prostate or breast cancer who are scheduled to undergo surgical lymph node dissection or sampling. Secondary * Correlate MRI signal intensity with histological findings in patients undergoing this procedure. OUTLINE: This is an open-label, pilot study. Patients undergo a baseline MRI. Within 24 hours after the baseline MRI, patients receive ferumoxytol IV over 10-15 seconds (or over 1 hour). Patients then undergo MRI immediately after ferumoxytol administration (at the discretion of the principal investigator) and then at 24-28 hours. Patients are followed at 2 weeks. PROJECTED ACCRUAL: A total of 10-14 patients (6-8 with prostate cancer and 4-6 with breast cancer) will be accrued for this study.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 14 pacientes
Número total de participantes que el ensayo clínico espera reclutar.Elegibilidad
Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.Cualquier sexo
Sexo biológico de los participantes elegibles para inscribirse.A partir de 18 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: * Histologically confirmed primary prostate or breast cancer * Suspected lymph node metastatic disease by standard MRI or CT scan * Scheduled for surgical lymph node dissection or sampling * Hormone receptor status: * Not specified PATIENT CHARACTERISTICS: Age * 18 and over Sex * Not specified Menopausal status * Not specified Performance status * Not specified Life expectancy * Not specified Hematopoietic * No prior ferritin \> 800 ng/mL * No prior transferrin saturation \> 60% * No history of iron overload or hemachromatosis * Patients with a clinical history of suspected iron overload or hemachromatosis must have normal serum iron, ferritin, and transferrin saturation Hepatic * Bilirubin ≤ 2 times upper limit of normal (ULN) * SGOT ≤ 2 times ULN Renal * Not specified Other * No requirement for monitored anesthesia during MRI * No known allergic or hypersensitivity reaction to any of the following parenterally-administered preparations: * Iron * Dextran * Iron dextran * Iron polysaccharide * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception for at least 1 month before and during study participation PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * Not specified Endocrine therapy * Not specified Radiotherapy * Not specified Surgery * Not specified Other * No prior therapy for metastatic disease
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 una ubicación