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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02617264
• Other study ID #: KaplanMC
• Status: Not yet recruiting
• Phase: N/A
• First received: October 26, 2015
• Last updated: December 1, 2015
• Start date: January 2016
• Est. completion date: March 2017

Study information

• Verified date: December 2015
• Source: Kaplan Medical Center
• Contact: Tanir Allweis, MD
• Email: taniral[@]clalit.org.il
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: March 2017
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Procedure:
• SPOT
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.

Locations

Country	Name	City	State
Israel	Kaplan Medical Center	Rehovot

Sponsors (1)

Lead Sponsor	Collaborator
Kaplan Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intra operative identification the Spot TM marked node at the time of surgery		Within 1 year of enrollment	No
Secondary	Correlation between Spot TM marked lymph node and sentinel lymph node		Within 1 year of enrollment	No