- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT04879680
Indocyanine Green Fluorescence-guided Sentinel Node Biopsy in Breast Cancer Within a North African Population: a Retrospective Study
Background Radio Isotopes and Blue dye alone or in combination are the most commonly used tracer agents in sentinel Node Biopsy for early breast cancer. Recent studies have found fluorescence method using Indo Cyanine Green as a promising technology with fewer disadvantages. This study represents the first within a North African setting.
Methods Retrospective analysis of our database that includes patients with clinically node-negative breast cancer scheduled for breast surgery and SN biopsy between 2016 and January 2021. Patients who underwent detection using fluorescence-ICG were included in this study.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
We performed a retrospective review our data base that includes breast cancer planned for sentinel node biopsy at the F. Hached University teaching hospital(Sousse, Tunisia). Data between April 2016 and January 2021 were reviewed. Only non-pregnant or lacting adult female patients without palpable clinical node and considered suitable for such procedure at multidisciplinary meeting were included. We excluded from our analysis the first ten cases considered as a learning curve Same operator (SH) carried out all the procedures.
Under general anesthesia 5 ml at 2.5mg/ml of Infracyanine ® were injected circumferentially around the areola. Two ml of patent blue-V dye (Laboratoire Guerbet, Aulney-Sous-Bois, France) were injected in combination in the cohort of patients undergoing the procedure after primary chemotherapy. This was followed by a breast massage to facilitate absorption into the lymph vessels, then the surgical lights were turned off and image were obtained under near-infrared light using a first generation Near Infra Red device . Course of subcutaneous lymphatic drainage pathway fluorescence was followed up to where it disappeared to enter to deeper axilla and an incision was performed at that place. Lymphatic duct identification using the NIR camera allowed localization and removal of the sentinel lymph node(s). Further fluorescent imaging was performed to identify potential residual signal in the axilla and such signal-sites were removed. Following ICG assisted-dissection, blue-stained nodes were excised if any. All detected sentinel node were send for frozen section and processed for histological examination. After sentinel node biopsy, conservative surgery or mastectomy were performed according to indication and axillary dissection was performed according to international guidelines.
Statistical analysis Baseline patient's and tumor characteristics, Identification Rate of the sentinel node with Indocyanine green and with dye , when used, were recorded. Data were entered and analyzed in Excel. The continuous variables are presented as mean ± standard deviation and categorical variables are presented as count and percentages unless specified. Informed consents from each patient and IRB approval were obtained
Tipo de estudio
Inscripción (Actual)
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- non-pregnant or lacting adult female patients with breast cancer without palpable clinical node and considered suitable for such procedure at multidisciplinary meeting were included
Exclusion Criteria:
- Non eligible patient for breast cancer sentinel node procedure
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
identification rate
Periodo de tiempo: 5 years
|
percentage of cas in whom sentinel node was identified with fluoresence method
|
5 years
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Samir Hidar, Prof. M.D, F.Hached university teaching hospital
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
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
Otros números de identificación del estudio
- CEFMS 82/2021
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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 Cáncer de mama
-
Tianjin Medical University Cancer Institute and...Guangxi Medical University; Sun Yat-sen University; Chinese PLA General Hospital; The First Affiliated Hospital of Zhengzhou University y otros colaboradoresTerminadoLa guía de aplicación clínica de Conebeam Breast CTPorcelana
-
Istanbul Aydın UniversityTerminado
-
Abramson Cancer Center of the University of PennsylvaniaTerminadoPaciente con cancerEstados Unidos
-
Peking Union Medical College HospitalTerminadoEncuesta | Estado nutricional | Paciente con cancerPorcelana
-
Northwestern UniversityGenzyme, a Sanofi CompanyRetiradoCANCER DE PROSTATAEstados Unidos
-
Ankara Medipol UniversityReclutamientoCuidados personales | Inmunoterapia | Manejo de síntomas | Paciente con cancerPavo
-
University of Colorado, DenverColorado State UniversityRetiradoRealidad virtual | Diagnóstico por imagen | Educación del paciente | Paciente con cancerEstados Unidos
-
Fundacao ChampalimaudTerminado
-
University College London HospitalsTerminado
-
GenSpera, Inc.RetiradoCancer de prostata.Estados Unidos
Ensayos clínicos sobre sentinel node detection
-
Johnson & Johnson Medical, ChinaTerminadoCáncer de mamaPorcelana
-
First Sense Medical, LLCUniversity of Toledo Health Science CampusSuspendidoNeoplasia mamaria femenina | Cáncer de mama | TermografíaEstados Unidos
-
Boston Scientific CorporationTerminadoCarreraEstados Unidos, Dinamarca, Francia, Alemania, Australia, Italia
-
WepromSIVAN Innovation LdtTerminado
-
miR Scientific LLCActivo, no reclutandoCancer de prostataPuerto Rico
-
Claret MedicalTerminadoReemplazo de válvula aórtica transcatéter | Estenosis de válvula aórtica nativa calcificada sintomática severa
-
Janssen Diagnostics, LLCTerminado
-
Janssen Diagnostics, LLCTerminadoCáncer de mamaEstados Unidos
-
Brain SentinelDesconocidoConvulsión, no epiléptica
-
Brain SentinelTerminadoEpilepsia | Convulsiones tónico-clónicas generalizadasEstados Unidos