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

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ClinicalTrials.gov Identifier: NCT01771666
Recruitment Status : Completed
First Posted : January 18, 2013
Results First Posted : December 11, 2017
Last Update Posted : December 11, 2017
Sponsor:
Information provided by (Responsible Party):
Irene L. Wapnir, Stanford University

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Device: SPY Elite Imaging Drug: Indocyanine Green Drug: Isosulfan blue Drug: 99technetium-sulfur colloid radiolabel Phase 2

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: A Pilot Study to Assess the Utility of Indocyanine Green™ (IC-GREEN™) SPY Imaging in the Mapping of Arm Draining Lymphatics and Nodes During Sentinel Node Resection With or Without Axillary Dissection in Breast Cancer
Study Start Date : July 2012
Actual Primary Completion Date : March 17, 2015
Actual Study Completion Date : March 17, 2015


Arm Intervention/treatment
Experimental: 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.

Device: 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

Drug: Indocyanine Green

started at 1mg /mL

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

Other Names:
  • IC-GREEN
  • ICG

Drug: Isosulfan blue

3 to 5 mL

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

Other Names:
  • IS-BLUE
  • ISB
  • Lymphazurin

Drug: 99technetium-sulfur colloid radiolabel
Other Name: 99tech




Primary Outcome Measures :
  1. Agreement of Labeling Between Isosulfan Blue (IS-BLUE) and Indocyanine Green (IC-GREEN) [ Time Frame: 1 day ]
    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.


Secondary Outcome Measures :
  1. Detection of Indocyanine Green (IC-GREEN); Isosulfan Blue (IS-BLUE); and 99technetium-sulfur Colloid Radiolabel in Resected Sentinel Nodes [ Time Frame: 1 day ]

    The outcome is expressed as the number of participants whose resected sentinel lymph nodes (SLN) bound 99technetium-sulfur colloid (99tech), a tumor marker radiolabel; Indocyanine Green (IC-GREEN; "GREEN"), a fluorescent label; or isosulfan blue (IS-BLUE; "BLUE"), a visual dye. Results are expressed as:

    • "Any HOT" = Those whose samples bound 99tech.
    • "Not HOT" = Those whose samples did not bind 99tech.
    • "Not HOT (also no BLUE, no GREEN)" = Those whose samples did not bind 99tech; and also did not bind IC-GREEN nor IS-BLUE.
    • "HOT, BLUE, GREEN" = Those whose samples bound all of 99tech; IC-GREEN; and IS-BLUE.
    • "HOT, no BLUE, no GREEN" = Those whose samples bound 99tech, but did not bind either of IC-GREEN nor IS-BLUE.
    • "HOT, GREEN only, no BLUE" = Those whose samples bound 99tech and IC-GREEN, but did not bind IS-BLUE.



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01771666


Locations
United States, California
Stanford University, School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Irene Wapnir Stanford University

Responsible Party: Irene L. Wapnir, Professor - Med Center Line, Surgery - General Surgery, Stanford University
ClinicalTrials.gov Identifier: NCT01771666     History of Changes
Other Study ID Numbers: IRB-21030
SU-06122012-10130 ( Other Identifier: Stanford University )
BRS0022 ( Other Identifier: OnCore )
First Posted: January 18, 2013    Key Record Dates
Results First Posted: December 11, 2017
Last Update Posted: December 11, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Technetium Tc 99m Sulfur Colloid
Radiopharmaceuticals
Molecular Mechanisms of Pharmacological Action