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

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Stanford University

Status and phase

Completed
Phase 2

Conditions

Breast Cancer

Treatments

Drug: Indocyanine Green
Drug: 99technetium-sulfur colloid radiolabel
Drug: Isosulfan blue
Device: SPY Elite Imaging

Study type

Interventional

Funder types

Other

Identifiers

NCT01771666
SU-06122012-10130 (Other Identifier)
IRB-21030
BRS0022 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

23 patients

Sex

Female

Ages

18 to 90 years old

Volunteers

No 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.

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

23 participants in 1 patient group

ISB and ICG
Experimental group
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.
Treatment:
Device: SPY Elite Imaging
Drug: Isosulfan blue
Drug: 99technetium-sulfur colloid radiolabel
Drug: Indocyanine Green

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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