Spot tm Tattooing of Biopsied Axillary Lymph Nodes With Ultrasound Guided in Breast Cancer Patients Prior to Surgery

Kaplan Medical Center

Status: Unknown

Conditions: Breast Cancer

Treatments: Procedure: SPOT

Study type: Interventional

Funder types: Other

Identifiers

NCT02617264

KaplanMC

Details and patient eligibility

About

To assess feasibility and clinical utility of marking biopsied axillary lymph nodes with Spot at time of biopsy.

Full 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.

Enrollment: 50 estimated patients

Sex: Female

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Axillary lymph node FNA Biopsy

Experimental group

Description:

A carbon compound ink (SPOT) is injected to the axillary lymph node suspected to be infected with cancer

Treatment:

Procedure: SPOT