- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00067418
Light Scattering Spectroscopy to Determine Brain Tumors
Spectroscopic Determination of Brain Tumor Cells
This study will use light scattering spectroscopy (LSS) to analyze brain tissue removed from patients during brain surgery to determine if this new technology can be used to differentiate between normal and cancerous cells. LSS focuses light on cells or tissues, and the way that light is reflected back from the tissues provides information about the size of cells and the density of the cell nuclei (the part of the cell that contains the genes).
Patients between 18 and 75 years of age with a known or suspected brain tumor and patients with temporal lobe epilepsy that does not respond to medication may be eligible for this study. (Examination of tissue from patients with epilepsy will allow comparison of tumor and non-tumor brain cells.) All patients must require surgery to treat their condition.
Participants will be admitted to the Clinical Center for 3 to 10 days for physical and neurological examinations, blood and urine tests, and other tests needed to prepare for surgery. They will then undergo surgery. A small amount of tissue removed during surgery for pathological review will be collected for use in this study.
Half of the tissue will be examined using LSS to help determine the size of the cell and its nucleus. Studies will be done to measure how many of the cells are actively dividing and which proteins are expressed more often in tumor cells compared with normal cells. This information may shed light on how tumor cells are different from normal cells.
Participants may be contacted for up to 3 years to follow their health status.
Descripción general del estudio
Estado
Condiciones
Descripción detallada
Optical spectroscopy for detection of brain tumors and tumor margins has been shown to be of use in distinguishing gliomas and metastatic tumor cells from surrounding white matter. Optical spectroscopy has the potential to provide immediate and accurate diagnostic information about the nature and quantity of neoplastic cells, in a minimally-or non-invasive fashion. We propose to use a new method of optical spectroscopy, polarized light-scattering spectroscopy (LSS), which permits discrimination of malignant cancer cells from normal brain cells by virtue of alterations in the cytoplasmic and nuclear ratios of these cells.
Patients suspected of having, or with prior biopsy proof of, a WHO grade II-IV central nervous system (CNS) glial tumor(s); those with metastatic brain tumor; or patients with medically-refractory temporal lobe epilepsy with a presumed hippocampal source of seizures, who are seen in the Surgical Neurology Branch, NINDS, will be considered for entry into this study. Tissue samples of tumor or normal lateral temporal neocortex resected as part of standard care will be collected at surgery and utilized for research.
Tipo de estudio
Inscripción
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Maryland
-
Bethesda, Maryland, Estados Unidos, 20892
- National Institute of Neurological Disorders and Stroke (NINDS)
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
INCLUSION CRITERIA:
- Radiographic evidence of primary glial neoplasm of the CNS (WHO grade II-IV) or any patient with a known primary neoplasm of the CNS; patients with a known or with radiographic evidence of resectable metastatic brain tumor(s); or patients with temporal lobe epilepsy (TLE) in whom resective surgery, which will include the lateral termporal neocortex, is indicated.
- Informed consent from patients age 18 or older.
- No racial or ethnic group or gender is excluded.
- Pregnant women who require brain surgery may participate in this study.
EXCLUSION CRITERIA:
- Inability to provide informed consent prior to surgery.
- Medical conditions that cannot be corrected prior to surgery that would be standard contraindications for neurosurgery.
Plan de estudios
¿Cómo está diseñado el estudio?
Colaboradores e Investigadores
Publicaciones y enlaces útiles
Publicaciones Generales
- Louis DN, Pomeroy SL, Cairncross JG. Focus on central nervous system neoplasia. Cancer Cell. 2002 Mar;1(2):125-8. doi: 10.1016/s1535-6108(02)00040-5. No abstract available.
- Lacroix M, Abi-Said D, Fourney DR, Gokaslan ZL, Shi W, DeMonte F, Lang FF, McCutcheon IE, Hassenbusch SJ, Holland E, Hess K, Michael C, Miller D, Sawaya R. A multivariate analysis of 416 patients with glioblastoma multiforme: prognosis, extent of resection, and survival. J Neurosurg. 2001 Aug;95(2):190-8. doi: 10.3171/jns.2001.95.2.0190.
- Silbergeld DL, Chicoine MR. Isolation and characterization of human malignant glioma cells from histologically normal brain. J Neurosurg. 1997 Mar;86(3):525-31. doi: 10.3171/jns.1997.86.3.0525.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización del estudio
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades Cerebrales
- Enfermedades del Sistema Nervioso Central
- Enfermedades del Sistema Nervioso
- Síndromes epilépticos
- Neoplasias
- Neoplasias por sitio
- Neoplasias del Sistema Nervioso Central
- Neoplasias del Sistema Nervioso
- Epilepsia
- Epilepsias Parciales
- Neoplasias Cerebrales
- Epilepsia, Lóbulo Temporal
Otros números de identificación del estudio
- 030270
- 03-N-0270
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. .
Ensayos clínicos sobre Epilepsia, Lóbulo Temporal
-
National Institute of Mental Health (NIMH)TerminadoEpilepsia | Lóbulo temporalEstados Unidos
-
Galderma R&DActivo, no reclutandoVaciado TemporalEstados Unidos
-
The University of Texas Health Science Center,...National Institute of Neurological Disorders and Stroke (NINDS)ReclutamientoEpilepsia del lóbulo temporal mesialEstados Unidos
-
University Hospital, BrestReclutamientoEstudio Imagenológico de Variaciones Anatómicas de la Arteria Temporal Superficial (EVATSI) (EVATSI)Arteria temporal superficialFrancia
-
Misr International UniversityZinedentActivo, no reclutandoRestauración Dental TemporalEgipto
-
National Institute of Neurological Disorders and...TerminadoEpilepsia | Lóbulo temporalEstados Unidos
-
Cairo UniversityTerminado
-
Gérond'ifTerminadoPacientes Beneficiarios de Hebergement TemporalFrancia
-
LG Life SciencesTerminado
-
Emory UniversityTerminadoEpilepsia del lóbulo temporal mesialEstados Unidos