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Pilot Indocyanine Green Imaging for Mapping of Arm Draining Lymphatics & Nodes in Breast Cancer

NCT ID: NCT01771666

Last Updated: 2017-12-11

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-31

Study Completion Date

2015-03-17

Brief Summary

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The purpose of this study is to determine if Indocyanine Green (IC-GREEN) is comparable to isosulfan blue (IS-BLUE) in the identification of arm lymphatics and arm-draining nodes during nodal staging procedures in breast cancer.

Detailed Description

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It is the objective of the current study to test Indocyanine Green (IC-GREEN) as an agent for mapping arm draining lymphatics and nodes and compare it to isosulfan blue (IS-BLUE) in the setting of sentinel node procedures with or without axillary node dissections in women with breast cancer. All participants will also have tumor samples evaluated with 99technetium-sulfur colloid, a radiolabel used to identify tumor markers.

Conditions

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Breast Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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ISB and ICG

The dose of Isosulfan blue (ISB) dye and Indocyanine green (ICG) solution will be started.

(IC-GREEN) SPY Elite Imaging willbe used to capture the images of axillary cavity.

Group Type EXPERIMENTAL

SPY Elite Imaging

Intervention Type DEVICE

A camera that is directed into the axillary cavity to try to capture an image of the tumor site labeled with Indocyanine green before and after excising sentinel nodes

Indocyanine Green

Intervention Type DRUG

started at 1mg /mL

If fluorescence is not detected with this dose, then it will be increased by 50%.

Isosulfan blue

Intervention Type DRUG

3 to 5 mL

If fluorescence is not detected with this dose, then it will be increased by 50%.

99technetium-sulfur colloid radiolabel

Intervention Type DRUG

Interventions

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SPY Elite Imaging

A camera that is directed into the axillary cavity to try to capture an image of the tumor site labeled with Indocyanine green before and after excising sentinel nodes

Intervention Type DEVICE

Indocyanine Green

started at 1mg /mL

If fluorescence is not detected with this dose, then it will be increased by 50%.

Intervention Type DRUG

Isosulfan blue

3 to 5 mL

If fluorescence is not detected with this dose, then it will be increased by 50%.

Intervention Type DRUG

99technetium-sulfur colloid radiolabel

Intervention Type DRUG

Other Intervention Names

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IC-GREEN ICG IS-BLUE ISB Lymphazurin 99tech

Eligibility Criteria

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Inclusion Criteria

* Ability to understand and the willingness to sign a written informed consent document.
* Signed written informed consent.
* Women undergoing sentinel lymph node biopsy.
* Women with breast cancer with known or suspected lymph node involvement.
* Women undergoing sentinel node identification and completion axillary lymph node dissection.
* Women of 18 years of age or older.
* Eastern Cooperative Oncology Group (ECOG) or Karnofsky Performance Status 0,1,2.
* Complete Blood Count (CBC) and basic Metabolic Panel within 6 months

Exclusion Criteria

* History of liver or kidney failure will not be eligible.
* Allergies to iodine containing products will not be eligible.
* Women who are pregnant will not be eligible.
* Psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude the patient from meeting the study requirements.
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Stanford University

OTHER

Sponsor Role lead

Responsible Party

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Irene L. Wapnir

Professor - Med Center Line, Surgery - General Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Irene Wapnir

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

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Stanford University, School of Medicine

Stanford, California, United States

Site Status

Countries

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United States

Other Identifiers

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SU-06122012-10130

Identifier Type: OTHER

Identifier Source: secondary_id

BRS0022

Identifier Type: OTHER

Identifier Source: secondary_id

IRB-21030

Identifier Type: -

Identifier Source: org_study_id