NCT01771666

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
23

participants targeted

Target at below P25 for phase_2 breast-cancer

Timeline
Completed

Started Jul 2012

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

July 1, 2012

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

January 16, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 18, 2013

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 17, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 17, 2015

Completed
2.7 years until next milestone

Results Posted

Study results publicly available

December 11, 2017

Completed
Last Updated

December 11, 2017

Status Verified

November 1, 2017

Enrollment Period

2.7 years

First QC Date

January 16, 2013

Results QC Date

September 6, 2017

Last Update Submit

November 7, 2017

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • Agreement of Labeling Between Isosulfan Blue (IS-BLUE) and Indocyanine Green (IC-GREEN)

    Number of women with agreement of the two dies \[ie, isosulfan blue (IS-BLUE) and indocyanine green (IC-GREEN)\] on all nodes examined in the lymphatics and arm-draining lymph nodes, during nodal staging procedures for surgery to treat breast cancer with curative intent.

    1 day

Secondary Outcomes (1)

  • Detection of Indocyanine Green (IC-GREEN); Isosulfan Blue (IS-BLUE); and 99technetium-sulfur Colloid Radiolabel in Resected Sentinel Nodes

    1 day

Study Arms (1)

ISB and ICG

EXPERIMENTAL

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.

Device: SPY Elite ImagingDrug: Indocyanine GreenDrug: Isosulfan blueDrug: 99technetium-sulfur colloid radiolabel

Interventions

SPY Elite ImagingDEVICE

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

ISB and ICG
Indocyanine GreenDRUG

started at 1mg /mL If fluorescence is not detected with this dose, then it will be increased by 50%.

Also known as: IC-GREEN, ICG
ISB and ICG
Isosulfan blueDRUG

3 to 5 mL If fluorescence is not detected with this dose, then it will be increased by 50%.

Also known as: IS-BLUE, ISB, Lymphazurin
ISB and ICG
99technetium-sulfur colloid radiolabelDRUG
Also known as: 99tech
ISB and ICG

Eligibility Criteria

Age18 Years - 90 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University, School of Medicine

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Indocyanine Greeniso-sulfan blue

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

IndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Results Point of Contact

Title
Dr. Irene Wapnir
Organization
Stanford University
Wapnir@stanford.edu
650-724-1953

Study Officials

  • Irene Wapnir

    Stanford University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor - Med Center Line, Surgery - General Surgery

Study Record Dates

First Submitted

January 16, 2013

First Posted

January 18, 2013

Study Start

July 1, 2012

Primary Completion

March 17, 2015

Study Completion

March 17, 2015

Last Updated

December 11, 2017

Results First Posted

December 11, 2017

Record last verified: 2017-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)