Carbon Dye Tattooing of Biopsied Axillary Node in Breast Cancer
Palabras clave
Abstracto
Descripción
Pretreatment evaluation of axillary lymph nodes and marking of biopsied nodes in patients with newly diagnosed breast cancer is becoming routine practice. Tagging of biopsied axillary lymph nodes with metal markers, similar to what is done for suspicious breast lesions, is being adopted in clinical practice. The need to mark a positive axillary lymph node becomes especially relevant in cases where neoadjuvant chemotherapy (NACT) is anticipated so that these nodes may be identified at the time of surgery. Measures that improve both the accuracy of nodal evaluation after NACT and the ability to assess treatment response are desirable in order to tailor therapies for breast cancer treatment. The investigators sought to test tattooing of biopsied axillary lymph nodes with a sterile black carbon suspension (Spot dye). The concept is based on the experience in the gastrointestinal tract wherein tattooing is widely used for marking lesions or tumours biopsied during endoscopy. India ink tattoos of colonic lesions remain identifiable over a long period of time. Spot is routinely used in the UK for tattooing gastrointestinal tract lesions and is used to mark the axillary lymph nodes in breast cancer by some centres in the US and Europe. The intraoperative success of identifying tattooed axillary lymph nodes and their concordance to sentinel nodes will be determined.
fechas
| Verificado por última vez: | 05/31/2020 |
| Primero enviado: | 08/14/2018 |
| Inscripción estimada enviada: | 08/16/2018 |
| Publicado por primera vez: | 08/20/2018 |
| Última actualización enviada: | 06/28/2020 |
| Última actualización publicada: | 06/30/2020 |
| Fecha de inicio real del estudio: | 04/26/2018 |
| Fecha estimada de finalización primaria: | 07/30/2019 |
| Fecha estimada de finalización del estudio: | 07/30/2019 |
Condición o enfermedad
Intervención / tratamiento
Procedure: Tattooing of biopsied node
Fase
Grupos de brazos
| Brazo | Intervención / tratamiento |
|---|---|
| Experimental: Tattooing of biopsied node The biopsied node will be tattooed at the time of needle biopsy (fine needle aspiration or core biopsy) or separate visit under ultrasound guidance. | Procedure: Tattooing of biopsied node Tattooing (marking) of biopsied node with carbon dye (SPOT dye) at the time of fine needle aspiration or core biopsy or separate visit under ultrasound guidance. The dye will be injected in the cortex of the node and the perinodal tissue under ultrasound guidance. Patients will undergo standard (routine) armpit surgery and may receive neoadjuvant chemotherapy as planned by the clinical team. This could be removal of a few lymph glands (sentinel node biopsy) or removal of all the lymph glands (axillary lymph node dissection) in the armpit. The surgeon will try to identify and remove the tattooed lymph gland at the time of planned armpit surgery. |
Criterio de elegibilidad
| Edades elegibles para estudiar | 18 Years A 18 Years |
| Sexos elegibles para estudiar | All |
| Acepta voluntarios saludables | si |
| Criterios | Inclusion Criteria: - Age ≥ 18 - Male or female - Patients scheduled to undergo routine fine needle aspiration (FNA) or core biopsy of abnormal axillary lymph node - Invasive breast cancer - Written informed consent for the study Exclusion Criteria: - Not undergoing surgery or unfit for surgery |
Salir
Medidas de resultado primarias
1. Identification rate of tattooed node [12 months]
Medidas de resultado secundarias
1. Concordance of tattooed node and sentinel node [12 months]
2. Migration of black dye into other nodes [12 months]
