Nuclear and Near-Infrared (NIR) Imaging in Melanoma

Completed · Phase 1

Conditions studied: Melanoma

In brief

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.

Key facts

Study ID

NCT01295931

Run by

M.D. Anderson Cancer Center

People needed

20

Starts

2011-02-01

Expected to finish

2014-10-01

Last updated by the study team

2015-10-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.
• Persons who do not meet inclusion criteria.

Where it is running

• University of Texas MD Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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