Breast Cancer
Conditions
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.
Interventions
PROCEDURESPOT
Injecting the ink (SPOT) to the axillary lymph node prior the surgery. During the surgery the lymph nodes will be tasted to diagnose the marked node.
Sponsors
Kaplan Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Women with findings suspicious of breast cancer (or known breast cancer) who undergo axillary lymph node biopsy
Exclusion criteria
* Inability to sign Informed Consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Intra operative identification the Spot TM marked node at the time of surgery | Within 1 year of enrollment |
Secondary
| Measure | Time frame |
|---|---|
| Correlation between Spot TM marked lymph node and sentinel lymph node | Within 1 year of enrollment |
Countries
Israel
Contacts
Primary ContactTanir Allweis, MD
Backup ContactTanir Allweis, MD
Outcome results
None listed