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Last Updated: March 30, 2025

CLINICAL TRIALS PROFILE FOR FLUORESCITE


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All Clinical Trials for FLUORESCITE

Trial IDTitleStatusSponsorPhaseStart DateSummary
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.
NCT02691923 ↗ Diagnostic Performance of Fluorescein as an Intraoperative Brain Tumor Biomarker Recruiting Dartmouth-Hitchcock Medical Center 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.
NCT01886235 ↗ Intravital Microscopy for Identifying Tumor Vessels in Patients With Stage IA-IV Melanoma That is Being Removed by Surgery Completed National Cancer Institute (NCI) N/A 2013-09-04 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 Completed Roswell Park Cancer Institute N/A 2013-09-04 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.
NCT00847522 ↗ Fluorescein for Lymphatic Mapping and Sentinel Lymph Node (SLN) 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.
>Trial ID>Title>Status>Phase>Start Date>Summary
Showing 1 to 6 of 6 entries

Clinical Trial Conditions for FLUORESCITE

Condition Name

22220-0.200.20.40.60.811.21.41.61.822.2Stage IIIA Skin MelanomaStage IIIB Skin MelanomaStage IIA Skin MelanomaStage IIIC Skin Melanoma[disabled in preview]
Condition Name for FLUORESCITE
Intervention Trials
Stage IIIA Skin Melanoma 2
Stage IIIB Skin Melanoma 2
Stage IIA Skin Melanoma 2
Stage IIIC Skin Melanoma 2
[disabled in preview] 0
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Condition MeSH

3221000.511.522.53MelanomaHeart Septal DefectsSkin NeoplasmsHeart Septal Defects, Ventricular[disabled in preview]
Condition MeSH for FLUORESCITE
Intervention Trials
Melanoma 3
Heart Septal Defects 2
Skin Neoplasms 2
Heart Septal Defects, Ventricular 1
[disabled in preview] 0
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Clinical Trial Locations for FLUORESCITE

Trials by Country

+
Trials by Country for FLUORESCITE
Location Trials
United States 8
Canada 2
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Trials by US State

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

Clinical Trial Phase

20.0%10.0%30.0%40.0%011.522.533.54Phase 2Phase 1/Phase 2Phase 1[disabled in preview]
Clinical Trial Phase for FLUORESCITE
Clinical Trial Phase Trials
Phase 2 2
Phase 1/Phase 2 1
Phase 1 3
[disabled in preview] 4
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Clinical Trial Status

60.0%30.0%10.0%00123456CompletedRecruitingActive, not recruiting[disabled in preview]
Clinical Trial Status for FLUORESCITE
Clinical Trial Phase Trials
Completed 6
Recruiting 3
Active, not recruiting 1
[disabled in preview] 0
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Clinical Trial Sponsors for FLUORESCITE

Sponsor Name

trials011223344National Cancer Institute (NCI)Roswell Park Cancer InstituteNational Heart, Lung, and Blood Institute (NHLBI)[disabled in preview]
Sponsor Name for FLUORESCITE
Sponsor Trials
National Cancer Institute (NCI) 3
Roswell Park Cancer Institute 3
National Heart, Lung, and Blood Institute (NHLBI) 2
[disabled in preview] 4
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Sponsor Type

60.0%30.0%10.0%0024681012OtherNIHIndustry[disabled in preview]
Sponsor Type for FLUORESCITE
Sponsor Trials
Other 12
NIH 6
Industry 2
[disabled in preview] 0
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FLUORESCITE: Clinical Trials, Market Analysis, and Projections

Introduction

FLUORESCITE, a formulation of fluorescein sodium, is a diagnostic aid used primarily in fluorescein angiography and angioscopy of the retina and iris vasculature. Here, we delve into the current clinical trials, market analysis, and projections for this crucial diagnostic tool.

Clinical Trials and Research

Current Studies

While specific ongoing clinical trials for FLUORESCITE itself may be limited, the broader context of fluorescence-guided diagnostics and surgeries is vibrant. For instance, clinical trials involving fluorescence-guided surgery (FGS) systems, which often utilize fluorescein or similar compounds, are ongoing. A notable example is a clinical trial posted on ClinicalTrials.gov, sponsored by the Icahn School of Medicine at Mount Sinai, which aims to determine the effectiveness of 5-ALA (a fluorescent agent) in FGS for head and neck cancers. Such trials highlight the continuous research and development in the field of fluorescence-based diagnostics and surgeries[3].

Importance of Fluorescein in Clinical Trials

Fluorescein plays a critical role in various clinical trials due to its ability to provide high-resolution images of vascular structures. Its use in diagnostic angiography helps in the early detection and management of diseases such as age-related macular degeneration (AMD) and diabetic retinopathy. The outcomes of these trials often contribute to the advancement and validation of fluorescein-based diagnostic techniques[4].

Market Analysis

Global Market Size and Growth

The global fluorescein market is projected to experience steady growth, driven by the increasing prevalence of eye diseases and the need for advanced diagnostic tools. As of 2024, the global fluorescein market size is estimated to be in the hundreds of millions of dollars and is expected to grow at a compound annual growth rate (CAGR) of 5.30% from 2024 to 2031[2].

Regional Market Dynamics

  • North America: This region dominates the market, accounting for around 40% of the global revenue. The growth is driven by factors such as the increasing incidence of eye diseases, technological advancements in medical imaging, and a strong healthcare infrastructure[2].
  • Europe: Europe is the fastest-growing region, with a CAGR of 5.8% from 2024 to 2031. The growth is attributed to the rising incidence of eye diseases, advancements in medical imaging technologies, and increasing healthcare expenditures[2].
  • Asia Pacific: This region holds around 23% of the global revenue and is expected to grow at a CAGR of 7.3% from 2024 to 2031, driven by the increasing prevalence of chronic diseases and the need for advanced diagnostic tools[2].

Market Drivers

The market growth is driven by several key factors:

  • Increasing Incidence of Chronic Diseases: Conditions such as diabetes, cardiovascular diseases, and various types of cancer necessitate the use of advanced diagnostic tools like fluorescein angiography[5].
  • Aging Population: The aging population is more susceptible to age-related conditions, including eye diseases, which increases the demand for fluorescein-based diagnostics[5].
  • Technological Advancements: Improvements in medical imaging technologies and the development of new fluorescent agents and systems further boost the market[3].

Projections and Future Outlook

Market Growth Projections

The global fluorescein market is expected to expand significantly over the next few years. By 2031, the market is projected to reach a size that reflects a substantial increase from its current value, driven by the factors mentioned above[2].

Emerging Trends

  • Fluorescence-Guided Surgery: The increasing adoption of fluorescence-guided surgery systems, which often utilize fluorescein or similar compounds, is expected to drive market growth. These systems are anticipated to reach a market size of USD 263.95 million by 2030, growing at a CAGR of 16.26% from 2025 to 2030[3].
  • Precision Medicine: The rise of precision medicine and the demand for non-invasive diagnostic techniques will continue to drive the need for fluorescein and other fluorescent agents in medical diagnostics[5].

Key Takeaways

  • Clinical Trials: Ongoing clinical trials, particularly in the broader context of fluorescence-guided diagnostics and surgeries, continue to validate and advance the use of fluorescein.
  • Market Growth: The global fluorescein market is expected to grow at a CAGR of 5.30% from 2024 to 2031, driven by increasing eye disease prevalence and technological advancements.
  • Regional Dynamics: North America and Europe are key regions driving market growth, with Asia Pacific also showing significant potential.
  • Market Drivers: The aging population, increasing incidence of chronic diseases, and technological advancements are primary drivers of market growth.

FAQs

What is FLUORESCITE used for?

FLUORESCITE is used for diagnostic angiography or angioscopy of the retina and iris vasculature, helping in the early detection and management of eye diseases such as age-related macular degeneration (AMD) and diabetic retinopathy[4].

What are the key drivers of the global fluorescein market?

The key drivers include the increasing incidence of chronic diseases, the aging population, and technological advancements in medical imaging technologies[5].

Which regions are expected to drive the growth of the fluorescein market?

North America and Europe are currently the dominant regions, with Asia Pacific expected to show significant growth in the coming years[2].

What is the projected CAGR for the global fluorescein market from 2024 to 2031?

The global fluorescein market is expected to grow at a CAGR of 5.30% from 2024 to 2031[2].

How does fluorescein work in diagnostic procedures?

Fluorescein responds to electromagnetic radiation and light, emitting a yellowish-green fluorescence that helps in visualizing the retinal and choroidal vasculature under observation[4].

Sources

  1. FDA Label for FLUORESCITE: AccessData FDA, "FLUORESCITE® (fluorescein injection, USP) 10% Label".
  2. Cognitive Market Research: Cognitive Market Research, "Fluorescein Market Report 2024 (Global Edition)".
  3. Mordor Intelligence: Mordor Intelligence, "Fluorescence Guided Surgery Systems Market Size & Share Analysis".
  4. eMPR: eMPR, "FLUORESCITE Prescription & Dosage Information".
  5. Market Research Intellect: Market Research Intellect, "The Fluorescein Market Evolution Transforming Medical Diagnostics and Imaging Technologies".

More… ↓

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