Spot tm Tattooing of Biopsied Axillary Lymph Nodes With U... | NCT02617264

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

NCT02617264

Sponsor

Kaplan Medical Center

Status

Unknown status

Last Update Posted

Dec 2, 2015Estimated

Enrollment

50Estimated

Phase

Not Applicable

Conditions

Breast Cancer

Interventions

SPOT

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2015

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2016

Primary Completion Date

Oct 2016Estimated

Completion Date

Mar 2017Estimated

First Submitted Date

Oct 26, 2015

First Submission Date that Met QC Criteria

Nov 27, 2015

First Posted Date

Nov 30, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 1, 2015

Last Update Posted Date

Dec 2, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Tanir M Allweis, MD, Head of Department of Breast Health Center, Kaplan Medical CenterPrincipal Investigator

Lead Sponsor

Kaplan Medical CenterOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
SPOT	Procedure	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

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Tanir Allweis, MD	Contact			taniral@clalit.org.il
Tanir Allweis, MD	Contact	+972507874268		taniral@clalit.org.il

Overall Officials

Name	Affiliation	Role
Tanir Allweis, MD	Kaplan Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kaplan Medical Center		Rehovot		76100	Israel

Condition Browse Module

MeSH Terms

ID	Term
D001943	Breast Neoplasms

Ancestor Terms

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases

Browse Leaves

Not provided

Browse Branches

Not provided