Nuclear and Near-Infrared (NIR) Imaging in Melanoma
This study is currently recruiting participants.
Verified February 2013 by M.D. Anderson Cancer Center
Sponsor:
M.D. Anderson Cancer Center
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: February 25, 2013
Last verified: February 2013
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Purpose
Objectives:
- 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)
- 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 ]
| Estimated Enrollment: | 24 |
| Study Start Date: | February 2011 |
| Estimated Primary Completion Date: | February 2015 (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:
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01295931
Contacts
| Contact: Janice N. Cormier, MD, MPH, BS | 713-792-6940 |
Locations
| United States, Texas | |
| UT MD Anderson Cancer Center | Recruiting |
| Houston, Texas, United States, 77030 | |
| Contact: Janice N. Cormier, MD, MPH, BS 713-792-6940 | |
| Principal Investigator: Janice N. Cormier, MD, MPH, BS | |
Sponsors and Collaborators
M.D. Anderson Cancer Center
University of Texas
Investigators
| Principal Investigator: | Janice N. Cormier, MD, MPH, BS | UT MD 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 |
| Study First Received: | February 11, 2011 |
| Last Updated: | February 25, 2013 |
| Health Authority: | United States: Food and Drug Administration |
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 Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal |
Neoplasms by Histologic Type Neoplasms Neoplasms, Nerve Tissue Nevi and Melanomas |
ClinicalTrials.gov processed this record on May 21, 2013