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

Primary Purpose

Breast Cancer

Status

Unknown status

Phase

Not Applicable

Locations

Israel

Study Type

Interventional

Intervention

SPOT

About this trial

This is an interventional diagnostic trial for Breast Cancer

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

Kaplan Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Axillary lymph node FNA Biopsy

Arm Description

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

Outcomes

Primary Outcome Measures

Intra operative identification the Spot TM marked node at the time of surgery

Secondary Outcome Measures

Correlation between Spot TM marked lymph node and sentinel lymph node

Full Information

NCT ID

NCT02617264

First Posted

October 26, 2015

Last Updated

December 1, 2015

Sponsor

Kaplan Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT02617264

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2015

Overall Recruitment Status

Unknown status

Study Start Date

January 2016 (undefined)

Primary Completion Date

October 2016 (Anticipated)

Study Completion Date

March 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Kaplan Medical Center

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Axillary lymph node FNA Biopsy

Arm Type

Experimental

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

SPOT

Intervention Description

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.

Primary Outcome Measure Information:

Title

Intra operative identification the Spot TM marked node at the time of surgery

Time Frame

Within 1 year of enrollment

Secondary Outcome Measure Information:

Title

Correlation between Spot TM marked lymph node and sentinel lymph node

Time Frame

Within 1 year of enrollment

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Tanir Allweis, MD

taniral@clalit.org.il

First Name & Middle Initial & Last Name or Official Title & Degree

Tanir Allweis, MD

Phone

+972507874268

taniral@clalit.org.il

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Tanir Allweis, MD

Organizational Affiliation

Kaplan Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Kaplan Medical Center

City

Rehovot

ZIP/Postal Code

76100

Country

Israel

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Tanir M Allweis, MD

Phone

+972-50-7874268

taniral@clalit.org.il

First Name & Middle Initial & Last Name & Degree

Luda Levit, B.Sc

Phone

+972-52-6529297

ludale@clalit.org.il

First Name & Middle Initial & Last Name & Degree

Tanir M Allweis, MD

12. IPD Sharing Statement

Learn more about this trial

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

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