Fluorescein for Lymphatic Mapping and Sentinel Lymph Node Biopsy in Patients With Stage I and II Malignant Melanoma
The purpose of this research study is to use two different drugs to find where melanoma might spread and to remove these tissues. We believe that tumor cells from the melanoma first move through the lymphatic system (a system of clear fluid that moves around the body and carries white blood cells, much like the blood system) to a lymph node in an orderly way. If we can identify the first lymph nodes to receive a tumor cell, this can be removed and examined. We currently use one drug, called "technetium-99m sulfur colloid" which can detect about 90% of the first lymph nodes that the tumor cells would move to. Technetium-99m is a radioactive compound and can be detected through the skin by a special instrument that reads radioactivity. As part of this research, we would like to use a second drug called "fluorescein" (Fluorescite®) to see if it will identify the same lymph nodes or additional ones and examine these. This drug is fluorescent and can be detected even through the skin using a blue light. This drug is approved by the Federal Drug Administration (FDA) to for injection in the vein as a diagnostic aid and has been safely used in people for many years. In this study, we will be injecting it under the skin, which is a different use from how it is currently approved by the FDA. In the past another drug has been used, called "isosulfan blue" (Lymphazurin®), but availability of this drug is currently limited, and it has higher risks associated with it.
This study is being conducted by Dr. Robert Andtbacka, Dr. Dirk Noyes, Dr. James McGreevy and at University of Utah. This study is a Phase I/II and is done to find out if the drug can be used safely when given under the skin and if it will work for this purpose.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||Fluorescein for Lymphatic Mapping and Sentinel Lymph Node Biopsy in Patients With Stage I and II Malignant Melanoma|
- The primary goal of this study is to evaluate the ability of intradermal fluorescein to detect sentinel lymph nodes (SLNs) in patients with stage I and stage II melanoma. [ Time Frame: February 2014 ] [ Designated as safety issue: No ]
- To determine the co-localization between fluorescein and technetium-99m labeled sulfur colloid in SLNs. [ Time Frame: February 2014 ] [ Designated as safety issue: No ]
- To evaluate the ability to detect fluorescein fluorescence transdermally with a fluorometer. [ Time Frame: February 2014 ] [ Designated as safety issue: No ]
- To evaluate if there is a correlation between SLN ex-vivo fluorescent intensity and SLN ex-vivo gamma radiation intensity. [ Time Frame: February 2014 ] [ Designated as safety issue: No ]
- To evaluate if there is a correlation between SLN ex-vivo fluorescent intensity and SLN metastasis. [ Time Frame: February 2014 ] [ Designated as safety issue: No ]
- To evaluate if fluorescein fluorescence can be detected in the SLN after fixation and histological processing. [ Time Frame: February 2014 ] [ Designated as safety issue: No ]
- To evaluate the toxicity and safety of intradermal fluorescein injections. [ Time Frame: February 2014 ] [ Designated as safety issue: Yes ]
|Study Start Date:||February 2009|
|Estimated Study Completion Date:||July 2016|
|Estimated Primary Completion Date:||July 2016 (Final data collection date for primary outcome measure)|
Experimental: All patients
All participants enrolled.
Fluorescein is an orange-red powdered compound, designated by the formula C20H12O5, which exhibits intense greenish-yellow fluorescence in alkaline solution. It has been used extensively in surgery and medicine for decades for diagnostic purposes. Topical fluorescein is routinely used in ophthalmology to assess corneal lesions. Intravenous fluorescein is used in vascular surgery to measure vascular perfusion and in skin and melanoma surgery to assess the viability of skin flaps.
Other Name: Fluorescite®
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00847522
|United States, Utah|
|Huntsman Cancer Institute|
|Salt Lake City, Utah, United States, 84112|
|Principal Investigator:||Robert H Andtbacka, MD||Huntsman Cancer Institute|