Nuclear and Near-Infrared (NIR) Imaging in Melanoma

This study has been completed.
Sponsor:
Collaborators:
University of Texas
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01295931
First received: February 11, 2011
Last updated: October 13, 2014
Last verified: October 2014
  Purpose

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.

Condition Intervention Phase
Melanoma
Drug: Indocyanine Green (IC-Green)
Procedure: Imaging
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Diagnostic Nodal Staging for Melanoma With Nuclear and Near-Infrared (NIR) Molecular Optical Imaging

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Percentage of Nodes Identified by Indocyanine Green (ICG) Among All Resected Lymph Nodes [ Time Frame: 18-24 hours after procedure ] [ Designated as safety issue: No ]
    Procedure feasible if 18 out of 24 evaluable patients have 80% or more nodes identified by ICG among all resected nodes. Descriptive analyses performed to report the mean percentage and its 95% confidence interval of the nodes identified by ICG among the total resected nodes of all evaluable subjects. Outcome will be tabulated by age, different tumor stage, nodal status, and body mass index.


Enrollment: 20
Study Start Date: February 2011
Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: IC-Green + Imaging
Indocyanine Green (IC-Green) Injections + Imaging
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.
Other Name: ICG
Procedure: Imaging
Nonradioactive optical imaging with indocyanine green as a fluorescent contrast agent prior to sentinel lymph node biopsy or lymph node surgery.
Other Names:
  • near-infrared
  • NIR
  • NIR fluorescence imaging

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subjects must be 18 years of age or older
  2. Diagnosis of invasive melanoma with (ARM A) biopsy documenting a T2 (greater than 1 mm thickness) primary tumor undergoing standard of care sentinel lymph node biopsy (SLN) for definitive pathologic staging, OR (ARM B) documented node-positive (stage III) disease undergoing standard-of-care axillary or inguinofemoral lymph node dissection for regional disease control.
  3. Negative urine pregnancy test within 72 hours prior to study drug administration, if female of childbearing potential.
  4. Female of childbearing potential who agrees to use a medically accepted method of contraception for a period of one (1) month following the study. Medically acceptable contraceptives include (i) hormonal contraceptives such as birth control pills, Depo-Provera, or Lupron Depot) if such 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). Non-childbearing potential is defined as physiologically incapable of becoming pregnant, including any female who is post-menopausal; postmenopausal is defined as the time after which a woman has experienced 12 consecutive months of amenorrhea (lack of menstruation).
  5. For patients undergoing a complete axillary or inguinofemoral lymph node dissection a positive previous sentinel lymph node or a positive fine needle aspirate or core biopsy of their axillary or inguinofemoral lymph nodes.

Exclusion Criteria:

  1. Women who are pregnant or breast-feeding.
  2. Persons who are allergic to iodine
  3. A female of child-bearing potential who does not agree to use an approved contraceptive for one month after study participation.
  4. History of ipsilateral axillary or femoral surgery not including previous sentinel lymph node biopsy procedure.
  5. Persons who do not meet inclusion criteria.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01295931

Locations
United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
University of Texas
Investigators
Principal Investigator: Janice N. Cormier, MD, MPH, BS M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01295931     History of Changes
Other Study ID Numbers: 2010-0577, U54-CA136404
Study First Received: February 11, 2011
Last Updated: October 13, 2014
Health Authority: United States: Food and Drug Administration
United States: Federal Government

Keywords provided by M.D. Anderson Cancer Center:
Near-infrared
NIR
Indocyanine green
ICG
Melanoma
Fluorescent dyes
Lymph nodes
Experimental camera

Additional relevant MeSH terms:
Melanoma
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Neuroectodermal Tumors
Neuroendocrine Tumors
Nevi and Melanomas

ClinicalTrials.gov processed this record on October 21, 2014