Fluorescein for Lymphatic Mapping and Sentinel Lymph Node (SLN) Biopsy in Patients With Stage I and II Malignant Melanoma
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|ClinicalTrials.gov Identifier: NCT00847522|
Recruitment Status : Completed
First Posted : February 19, 2009
Results First Posted : December 20, 2017
Last Update Posted : December 20, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Cancer||Drug: Fluorescein||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||90 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||10 patients were enrolled in the Phase 1 portion of the trial. 80 patients were enrolled in the Phase 2 portion of the trial. 90 patients were enrolled total for the Phase 1 and 2 portions. Results are reported for the 80 patients on the Phase 2 portion.|
|Masking:||None (Open Label)|
|Official Title:||Fluorescein for Lymphatic Mapping and Sentinel Lymph Node Biopsy in Patients With Stage I and II Malignant Melanoma|
|Study Start Date :||February 2009|
|Actual Primary Completion Date :||July 2016|
|Actual Study Completion Date :||July 2016|
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®
- Percentage of Agreement Between the Detection of SLNs [ Time Frame: 2 days ]There is compete agreement if there are no SLNs that are either radioactive only or fluorescent only via intradermal fluorescein and technetium-99m labeled sulfur colloid.
- Safety Evaluation of Intradermal Fluorescein Injections. [ Time Frame: 1 month ]Number of participants that experienced an adverse event
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00847522
|United States, Utah|
|Huntsman Cancer Institute|
|Salt Lake City, Utah, United States, 84112|
|Principal Investigator:||Robert H Andtbacka, MD||Huntsman Cancer Institute|