Nuclear and Near-Infrared (NIR) Imaging in Melanoma

NCT01295931 | Completed Phase 1

• 2 other identifiers: 2010-0577U54CA136404
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Objectives:

1. 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. 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

Melanoma

Keywords

Near-infrared; NIR; Indocyanine green; ICG; Melanoma; Fluorescent dyes; Lymph nodes; Experimental camera

Outcome Measures

Primary Outcomes (1)

• Percentage of Nodes Identified by Indocyanine Green (ICG) Among All Resected Lymph Nodes

  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.

  18-24 hours after procedure

Study Arms (1)

IC-Green + Imaging

EXPERIMENTAL

Indocyanine Green (IC-Green) Injections + Imaging

Drug: Indocyanine Green (IC-Green); Procedure: Imaging

Interventions

Indocyanine Green (IC-Green) DRUG

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.

Also known as: ICG

IC-Green + Imaging

Imaging PROCEDURE

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

Also known as: near-infrared, NIR, NIR fluorescence imaging

IC-Green + Imaging

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects must be 18 years of age or older
• 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.
• Negative urine pregnancy test within 72 hours prior to study drug administration, if female of childbearing potential.
• 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).
• 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.

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 or femoral surgery not including previous sentinel lymph node biopsy procedure.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator
• University of Texas: collaborator

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Conditions

Melanoma

Interventions

Indocyanine Green; X-Rays; Spectroscopy, Near-Infrared

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Electromagnetic Radiation; Electromagnetic Phenomena; Magnetic Phenomena; Physical Phenomena; Radiation; Radiation, Ionizing; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Janice N. Cormier, MD, MPH, BS

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: February 11, 2011
• First Posted: February 15, 2011
• Study Start: February 1, 2011
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: October 7, 2015

Record last verified: 2015-10

Locations

US (1)