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

Primary Purpose

Breast Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
SPY Elite Imaging
Indocyanine Green
Isosulfan blue
99technetium-sulfur colloid radiolabel
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Breast Cancer

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Stanford University, School of Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ISB and ICG

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
January 16, 2013
Last Updated
November 7, 2017
Sponsor
Stanford University
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1. Study Identification

Unique Protocol Identification Number
NCT01771666
Brief Title
Pilot Indocyanine Green Imaging for Mapping of Arm Draining Lymphatics & Nodes in Breast Cancer
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 Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
March 17, 2015 (Actual)
Study Completion Date
March 17, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ISB and ICG
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
SPY Elite Imaging
Intervention Description
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
Drug
Intervention Name(s)
Indocyanine Green
Other Intervention Name(s)
IC-GREEN, ICG
Intervention Description
started at 1mg /mL If fluorescence is not detected with this dose, then it will be increased by 50%.
Intervention Type
Drug
Intervention Name(s)
Isosulfan blue
Other Intervention Name(s)
IS-BLUE, ISB, Lymphazurin
Intervention Description
3 to 5 mL If fluorescence is not detected with this dose, then it will be increased by 50%.
Intervention Type
Drug
Intervention Name(s)
99technetium-sulfur colloid radiolabel
Other Intervention Name(s)
99tech
Primary Outcome Measure Information:
Title
Agreement of Labeling Between Isosulfan Blue (IS-BLUE) and Indocyanine Green (IC-GREEN)
Description
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.
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Detection of Indocyanine Green (IC-GREEN); Isosulfan Blue (IS-BLUE); and 99technetium-sulfur Colloid Radiolabel in Resected Sentinel Nodes
Description
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.
Time Frame
1 day

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Irene Wapnir
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University, School of Medicine
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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