Spot tm Tattooing of Biopsied Axillary Lymph Nodes With Ultrasound Guided in Breast Cancer Patients Prior to Surgery
- Conditions
- Breast Cancer
- Interventions
- Procedure: SPOT
- Registration Number
- NCT02617264
- Lead Sponsor
- Kaplan Medical Center
- Brief Summary
To assess feasibility and clinical utility of marking biopsied axillary lymph nodes with Spot at time of biopsy.
- Detailed Description
As part of the diagnostic tests for breast cancer sometimes necessary to perform a FNA or Core biopsy to a suspicious axillary lymph node.
Presently there is no possibility to identify the examined gland at the surgery. If the gland was infected it's most important to remove it.
The only technique that exists today is marking with a metal clip and the use of this technique is not profit, partly because of technical difficulties.
In this trial the investigator will use a special ink which will be injected to the axillary lymph node during the biopsy and latter on the surgery the investigator will try to assess the ability to identify the marked gland.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 50
- Women with findings suspicious of breast cancer (or known breast cancer) who undergo axillary lymph node biopsy
- Inability to sign Informed Consent
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Axillary lymph node FNA Biopsy SPOT A carbon compound ink (SPOT) is injected to the axillary lymph node suspected to be infected with cancer
- Primary Outcome Measures
Name Time Method Intra operative identification the Spot TM marked node at the time of surgery Within 1 year of enrollment
- Secondary Outcome Measures
Name Time Method Correlation between Spot TM marked lymph node and sentinel lymph node Within 1 year of enrollment
Trial Locations
- Locations (1)
Kaplan Medical Center
🇮🇱Rehovot, Israel