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Last Updated: October 20, 2019

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CLINICAL TRIALS PROFILE FOR FLUORESCITE

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Clinical Trials for Fluorescite

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00847522 Fluorescein for Lymphatic Mapping and Sentinel Lymph Node Biopsy in Patients With Stage I and II Malignant Melanoma Completed University of Utah Phase 1/Phase 2 2009-02-01 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.
NCT01886235 Intravital Microscopy for Identifying Tumor Vessels in Patients With Stage IA-IV Melanoma That is Being Removed by Surgery Active, not recruiting National Cancer Institute (NCI) N/A 2013-09-01 This pilot clinical trial studies intravital microscopy for identifying tumor vessels in patients with stage IA-IV melanoma that is being removed by surgery. New imaging procedures, such as intravital microscopy, may determine the extent of melanoma.
NCT01886235 Intravital Microscopy for Identifying Tumor Vessels in Patients With Stage IA-IV Melanoma That is Being Removed by Surgery Active, not recruiting Roswell Park Cancer Institute N/A 2013-09-01 This pilot clinical trial studies intravital microscopy for identifying tumor vessels in patients with stage IA-IV melanoma that is being removed by surgery. New imaging procedures, such as intravital microscopy, may determine the extent of melanoma.
NCT02691923 Diagnostic Performance of Fluorescein as an Intraoperative Brain Tumor Biomarker Recruiting Carl Zeiss Meditec, Inc. Phase 2 2016-03-01 This clinical research will evaluate the diagnostic potential of fluorescein as visualized through an operating microscope relative to 1) contrast enhancement on co-registered preoperative MR scans, 2) intraoperative ALA-induced PpIX fluorescence and 3) gold-standard histology obtained from biopsy sampling during the procedure. Subjects will include those people with operable brain tumor with first-time presumed pre-surgical diagnosis of high-grade glioma or low-grade glioma.
NCT02691923 Diagnostic Performance of Fluorescein as an Intraoperative Brain Tumor Biomarker Recruiting National Institute of Neurological Disorders and Stroke (NINDS) Phase 2 2016-03-01 This clinical research will evaluate the diagnostic potential of fluorescein as visualized through an operating microscope relative to 1) contrast enhancement on co-registered preoperative MR scans, 2) intraoperative ALA-induced PpIX fluorescence and 3) gold-standard histology obtained from biopsy sampling during the procedure. Subjects will include those people with operable brain tumor with first-time presumed pre-surgical diagnosis of high-grade glioma or low-grade glioma.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Fluorescite

Condition Name

Condition Name for Fluorescite
Intervention Trials
Stage IIIA Skin Melanoma 2
Stage IIA Skin Melanoma 2
Stage IIIC Skin Melanoma 2
Stage IIC Skin Melanoma 2
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Condition MeSH

Condition MeSH for Fluorescite
Intervention Trials
Melanoma 3
Heart Septal Defects 2
Fallopian Tube Neoplasms 1
Carcinoma 1
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Clinical Trial Locations for Fluorescite

Trials by Country

Trials by Country for Fluorescite
Location Trials
United States 7
Canada 2
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Trials by US State

Trials by US State for Fluorescite
Location Trials
New York 3
Massachusetts 2
New Hampshire 1
Utah 1
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Clinical Trial Progress for Fluorescite

Clinical Trial Phase

Clinical Trial Phase for Fluorescite
Clinical Trial Phase Trials
Phase 2 2
Phase 1/Phase 2 1
Phase 1 3
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Clinical Trial Status

Clinical Trial Status for Fluorescite
Clinical Trial Phase Trials
Not yet recruiting 4
Recruiting 4
Completed 1
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Clinical Trial Sponsors for Fluorescite

Sponsor Name

Sponsor Name for Fluorescite
Sponsor Trials
Roswell Park Cancer Institute 3
National Cancer Institute (NCI) 3
National Heart, Lung, and Blood Institute (NHLBI) 2
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Sponsor Type

Sponsor Type for Fluorescite
Sponsor Trials
Other 10
NIH 6
Industry 2
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Serving leading biopharmaceutical companies globally:

Mallinckrodt
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McKinsey
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Boehringer Ingelheim

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