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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by Stanford University
Sponsor:
Information provided by (Responsible Party):
Stanford University
ClinicalTrials.gov Identifier:
NCT01771666
First received: January 16, 2013
Last updated: October 25, 2013
Last verified: October 2013
  Purpose

To determine concordance between isosulfan blue (ISB) and indocyanine green (IC-GREEN™) in the identification of lymphatics and arm-draining nodes during nodal staging procedures in breast cancer.


Condition Intervention
Breast Cancer
Device: (IC-GREEN™) SPY Elite® Imaging

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Percent of patients with blue and fluorescent lymphatics and nodes [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage of blue sentinel nodes or with ex-vivo fluorescence [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Estimated Enrollment: 15
Study Start Date: July 2012
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
ISB and IC-Green Dye
The dose of ISB dye is 3 to 5 mL and IC-Green™ will be started at 1 mg/mL. If fluorescence is not detected with this dose, then it will be increased by 50%. A gamma probe [Neoprobe 2010] will be used to localize the sentinel lymph nodes in the axilla.
Device: (IC-GREEN™) SPY Elite® Imaging

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Women undergoing sentinel node resection with or without axillary lymph node dissection (ALND) for breast cancer

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01771666

Contacts
Contact: Shannon Meyer 6507241953 smeyer27@stanford.edu

Locations
United States, California
Stanford University Cancer Institute Recruiting
Stanford, California, United States, 94305
Contact: Shannon Meyer    650-724-1953    smeyer27@stanford.edu   
Principal Investigator: Irene Wapnir         
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Irene Wapnir Stanford University
  More Information

No publications provided

Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT01771666     History of Changes
Other Study ID Numbers: BRS0022, SU-06122012-10130, 21030
Study First Received: January 16, 2013
Last Updated: October 25, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on August 26, 2014