Tattooing of Metastatic Axillary Lymph Node and Sentinel Lymph Node Biopsy after Neoadjuvant Chemotherapy in Breast Cancers

Feasibility study of tattoo for axillary lymph node metastasis prior to neoadjuvant chemotherapy in patient with breast cancer

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0002370

Enrollment

Registered

2017-07-07

Start date

2015-10-12

Completion date

Unknown

Last updated

2019-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Procedure/Surgery : 1. Node Tattooing Prior to neoadjuvant chemotherapy, the cytology-proven metastatic axillary lymph node is tattooed with charcoal suspension (Charcotrace

Phebra, Sydney, Australia) through ultrasound-guidance by a radiologist. To minimize obstacles to pathologic examination, the charcoal is mainly injected into the capsular area of the metastasis-confi

indigo carmine dye (Carmine

Korea United Pharm. Inc., Seoul, Republic of Korea) is injected into the periareolar area followed by a massage of the injection site.

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1) Age at the time of diagnosis over 19 years 2) Histologically confirmed breast cancer 3) Cytologically proven axillary lymph node metastasis by fine needle aspiration biopsy 4) Preoperatively administration of neoadjuvant chemotherapy

Exclusion criteria

Exclusion criteria: 1) Stage IV disease at diagnosis 2) Pase history of hypersensitivity or allergic reaction to charcoal agents 3) Inflammatory breast cancer 4) Pregnant or vulnerable patients 5) Patients unable to read or understand informed consents including foreigner 6) Clinician's decision of inappropriate patients to be enrolled

Design outcomes

Primary

Measure	Time frame
Identification rate of tattooed axillary node intraoperatively	—

Secondary

Measure	Time frame
Sensitivity, false negative rate, negative predictive value or accuracy of sentinel lymph node biopsy; Concordant rate or pathological characteristics between sentinel lympho nodes and tattooed lymph node	—

Countries

Korea, Republic of

Contacts

Public ContactSeho Park

Yonsei University Health System, Severance Hospital

psh1025@yuhs.ac+82-2-2228-2100

Outcome results