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

December 1, 2015 updated by: Tanir M Allweis, MD, Kaplan Medical Center
To assess feasibility and clinical utility of marking biopsied axillary lymph nodes with Spot at time of biopsy.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Rehovot, Israel, 76100
        • Kaplan Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Axillary lymph node FNA Biopsy
A carbon compound ink (SPOT) is injected to the axillary lymph node suspected to be infected with cancer
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Intra operative identification the Spot TM marked node at the time of surgery
Time Frame: Within 1 year of enrollment
Within 1 year of enrollment

Secondary Outcome Measures

Outcome Measure
Time Frame
Correlation between Spot TM marked lymph node and sentinel lymph node
Time Frame: Within 1 year of enrollment
Within 1 year of enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kaplan Medical Center

Investigators

  • Principal Investigator: Tanir Allweis, MD, Kaplan Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (Anticipated)

October 1, 2016

Study Completion (Anticipated)

March 1, 2017

Study Registration Dates

First Submitted

October 26, 2015

First Submitted That Met QC Criteria

November 27, 2015

First Posted (Estimate)

November 30, 2015

Study Record Updates

Last Update Posted (Estimate)

December 2, 2015

Last Update Submitted That Met QC Criteria

December 1, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KaplanMC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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