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Nuclear and Near-Infrared (NIR) Imaging in Melanoma

NCT01295931 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2015-10-07

No results posted yet for this study

Summary

Objectives:

1. To determine the feasibility of using microdose amounts of near-infrared (NIR) fluorescent contrast agent to image tumor-draining and contralateral lymphatics in melanoma patients prior to standard-of-care sentinel lymph node biopsy OR completion lymph node dissection (axillary or inguinofemoral)
2. To determine the feasibility of using nonradioactive optical imaging techniques with indocyanine green (ICG) as a fluorescent contrast agent to characterize lymphatic architecture and function by correlating the observed lymphatic structure and function with tumor and nodal status as determined from standard-of-care immunohistochemical evaluation.

Conditions

Interventions

DRUG

Indocyanine Green (IC-Green)

5 intradermal injections, 25 µg IC-Green in 0.1 mL of saline, in locations on the extremity (i.e. arm or leg) correlating with the tumor draining nodal basin to begin. Corresponding injections performed on the contralateral limbs.

PROCEDURE

Imaging

Nonradioactive optical imaging with indocyanine green as a fluorescent contrast agent prior to sentinel lymph node biopsy or lymph node surgery.

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • University of Texas

    collaborator OTHER

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Janice N. Cormier, MD, MPH, BS · M.D. Anderson Cancer Center

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-02-28
Primary Completion
2014-10-31
Completion
2014-10-31

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01295931 on ClinicalTrials.gov