NCT01095913

Brief Summary

The goal of this clinical research study is to find lymph nodes before surgery using a dye called indocyanine green (IC-Green). Objectives:

  1. 1.To determine the feasibility of using nonradioactive optical imaging techniques with indocyanine green (ICG) as a fluorescent contrast agent to identify all axillary lymph nodes.
  2. 2.To determine the feasibility of using nonradioactive optical imaging techniques with ICG as a fluorescent contrast agent to characterize lymphatic architecture and function in women with breast cancer who are scheduled for axillary node dissection.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at P25-P50 for phase_1 breast-cancer

Timeline
Completed

Started Mar 2010

Typical duration for phase_1 breast-cancer

Geographic Reach
1 country

2 active sites

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

March 1, 2010

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

March 26, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 30, 2010

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
Last Updated

January 8, 2015

Status Verified

January 1, 2015

Enrollment Period

3.8 years

First QC Date

March 26, 2010

Last Update Submit

January 7, 2015

Conditions

Breast Cancer

Keywords

Near-Infrared ImagingFluorescent DyesLymph Node MappingIndocyanine greenIC-Greennonradioactive optical imagingfluorescent contrast agentICGlymph nodesaxillary nodal dissection

Outcome Measures

Primary Outcomes (1)

  • Percentage of Nodes Identified by ICG Among All Resected Lymph Nodes for Each Patient

    Injection and Imaging procedure takes 1+ hour to complete

Study Arms (1)

IC-Green Injections

EXPERIMENTAL

ICG Injections performed after induction of anesthesia for surgery; 25 µg ICG/injection, with injections of 0.1 cc each to be made starting in the hand, arm, and areolar regions of the breast.

Drug: Indocyanine green (ICG)

Interventions

Indocyanine green (ICG)DRUG

Injections performed after induction of anesthesia for surgery; 25 µg ICG/injection, with injections of 0.1 cc each to be made starting in the hand, arm, and areolar regions of the breast.

Also known as: IC-Green
IC-Green Injections

Eligibility Criteria

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

You may qualify if:

  • Subjects must be 18 years of age or older
  • Diagnosis of breast cancer requiring axillary nodal dissection
  • Negative urine pregnancy test within 72 hours prior to study drug administration, if female of childbearing potential
  • Females of childbearing potential who agree to use a medically accepted method of contraception for a period of one month following the study. Medically acceptable contraceptives include (i) hormonal contraceptives (such as birth control pills, Depo-Provera, or Lupron Depot) if such use is approved by the subject's Oncologist; (ii) barrier methods (such as a condom or diaphragm) used with a spermicide, or (iii) an intrauterine device (IUD).
  • Patients with a positive fine needle aspirate or core biopsy of their axillary nodes

You may not qualify if:

  • Women who are pregnant or breast-feeding
  • Persons who are allergic to iodine
  • A female of child-bearing potential who does not agree to use an approved contraceptive for one month after study participation
  • History of ipsilateral axillary surgery including sentinel node biopsy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Texas Health Science Center - Houston

Houston, Texas, 77030, United States

Location

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Indocyanine Green

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Funda Meric-Bernstam, MD

    M.D. Anderson Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 26, 2010

First Posted

March 30, 2010

Study Start

March 1, 2010

Primary Completion

January 1, 2014

Study Completion

January 1, 2014

Last Updated

January 8, 2015

Record last verified: 2015-01

Locations

US(2)