NCT02617264

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable breast-cancer

Timeline
Completed

Started Jan 2016

Shorter than P25 for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 26, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 30, 2015

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2016

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

December 2, 2015

Status Verified

December 1, 2015

Enrollment Period

9 months

First QC Date

October 26, 2015

Last Update Submit

December 1, 2015

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

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

    Within 1 year of enrollment

Secondary Outcomes (1)

  • Correlation between Spot TM marked lymph node and sentinel lymph node

    Within 1 year of enrollment

Study Arms (1)

Axillary lymph node FNA Biopsy

EXPERIMENTAL

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

Procedure: SPOT

Interventions

SPOTPROCEDURE

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.

Axillary lymph node FNA Biopsy

Eligibility Criteria

Age18 Years - 80 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Women with findings suspicious of breast cancer (or known breast cancer) who undergo axillary lymph node biopsy

You may not qualify if:

  • Inability to sign Informed Consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kaplan Medical Center

Rehovot, 76100, Israel

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Tanir Allweis, MD

    Kaplan Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Tanir Allweis, MD

CONTACT

taniral@clalit.org.il

Tanir Allweis, MD

CONTACT

+972507874268taniral@clalit.org.il

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Department of Breast Health Center

Study Record Dates

First Submitted

October 26, 2015

First Posted

November 30, 2015

Study Start

January 1, 2016

Primary Completion

October 1, 2016

Study Completion

March 1, 2017

Last Updated

December 2, 2015

Record last verified: 2015-12

Locations

IL(1)