Multispectral Digital Colposcope With Probe for Detection of Cervical Intraepithelial Neoplasia (MDCwProbe)
Development and Application of a Multispectral Digital Colposcope and Probe Algorithm for Detection of Cervical Intraepithelial Neoplasia
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
The multispectral digital colposcope (MDC) is a specialized lightsource and imaging device mounted on a custom-made colposcope that acquires a sequence of fluorescence images. This version of the MDC incorporates an upgraded light source, and updates the firmware and the user interface. This results in shorter acquisition times and improved image and spectrum quality control. The MDC also consists of a point probe that is used to take detailed light measurements (call spectroscopy) from smaller regions of the cervix. The goal of the study is to see whether the MDC can perform better than standard methods in detecting cancerous or pre-cancerous abnormalities of the cervix.
Study subjects will be swabbed for detection and typing of the Human Papilloma Virus (HPV). After vinegar is applied on the cervix as per usual colposcopy practice, the MDC will then be used to take a sequence of images of the cervix. Next 2-4 readings will be taken from the cervix using the point probe.
This data will be used to train, test and validate an algorithm specific to the MDC. The ability of the algorithm to detect cervical intraepithelial neoplasia will be compared to standard clinical care (colposcopy).
The MDC images and pathology results will be compared to the spectroscopy data from the MDC probe. The investigators will determine if spectroscopy has equal sensitivity to colposcopy for detecting high grade lesions.
Tipo de estudio
Inscripción (Anticipado)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
New York
-
Brooklyn, New York, Estados Unidos, 11212
- Reclutamiento
- Brookdale University Hospital and Medical Center
-
Contacto:
- Leonid Fradkin, PhD
- Número de teléfono: 718-240-8225
- Correo electrónico: lfradkin@bhmcny.org
-
Contacto:
- Thelma Carrillo, MPH
- Número de teléfono: 718-240-5978
- Correo electrónico: tcarrill@bhmcny.org
-
Investigador principal:
- Michele Follen, MD, PhD
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Women who are at least 18 years old
- Are not pregnant (negative urine test) or breastfeeding
- Referred for colposcopy or LEEP treatment
- Can provide written informed consent
Exclusion Criteria:
- Women who do not meet the inclusion criteria
- Women who have had a hysterectomy
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Diagnóstico
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Routine colposcopy and MDC with probe
The intervention which consists of obtaining cervical images with the MDC and spectroscopic data with the probe will be applied to all participants who agreed to participate in the study during their visit for a colposcopy exam or treatment with a LEEP procedure.
A control biopsy will also be obtained from patients who agree to provide it.
The control biopsy is a biopsy of cervical tissue that does not appear to have atypical changes when observed through a standard of care colposcope.
|
Cervical images will be obtained with the Multispectral Digital Colposcope. Spectroscopic data will be obtained with the probe from eligible patients who provided consent to participate in the study. The standard of care for research participants will not change. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Detection of precancerous cervical lesions or cervical cancer
Periodo de tiempo: At point of care for colposcopy or treatment with LEEP (5 minutes).
|
Eligible patients who are referred to the colposcopy clinic for a diagnosis following an abnormal Pap smear will be asked to participate in the study. All participating women will receive their standard of care colposcopy as usual. In addition to their routine care, the MDC with probe will also be used to collect images of the cervix and spectroscopic measurements with the probe. All measurements will be compared with the biopsies obtained. The MDC with probe will not be used to determine from where the biopsies need to be obtained. One or two additional biopsies will be obtained from tissue that appears to be unaffected. These will be the control biopsies. Patients may refuse to provide the additional biopsies which are not part of the standard of care. Patients scheduled for a treatment with the Loop Electrosurgical Excision Procedure (LEEP) will be asked for consent to obtain one or two biopsies prior to the LEEP procedure, but after anesthesia has been applied. |
At point of care for colposcopy or treatment with LEEP (5 minutes).
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Michele Follen, MD, PhD, Brookdale University Hospital and Medical Center
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
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
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 14-35
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. .