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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
Sponsor:
Information provided by (Responsible Party):
University of Utah

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition Cancer
Intervention Drug: Fluorescein
Enrollment 90
Recruitment Details  
Pre-assignment Details  
Arm/Group Title All Patients
Hide Arm/Group Description

Phase II study with dose of VST-001 set at 5ml fluorescein sodium 0.01% solution administered intradermally for intraoperative lymphatic mapping in patients with Stage I or II malignant melanoma.

Fluorescein: 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.
Period Title: Overall Study
Started 90
Phase I 10
Phase II 80
Completed 90
Not Completed 0
Arm/Group Title All Patients
Hide Arm/Group Description

All participants enrolled.

Fluorescein: 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.
Overall Number of Baseline Participants 90
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 90 participants
50.5
(24 to 88)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 90 participants
Female
38
  42.2%
Male
52
  57.8%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 90 participants
90
 100.0%
1.Primary Outcome
Title Percentage of Agreement Between the Detection of SLNs
Hide Description 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.
Time Frame 2 days
Hide Outcome Measure Data
Hide Analysis Population Description
Total number of patients with at least one SLN was 89
Arm/Group Title All Patients
Hide Arm/Group Description:

Phase II study with dose of VST-001 set at 5ml fluorescein sodium 0.01% solution administered intradermally for intraoperative lymphatic mapping in patients with Stage I or II malignant melanoma.

Fluorescein: 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.
Overall Number of Participants Analyzed 89
Measure Type: Number
Unit of Measure: percentage complete agreement
69.7
2.Secondary Outcome
Title Safety Evaluation of Intradermal Fluorescein Injections.
Hide Description Number of participants that experienced an adverse event
Time Frame 1 month
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title All Patients
Hide Arm/Group Description:

Phase II study with dose of VST-001 set at 5ml fluorescein sodium 0.01% solution administered intradermally for intraoperative lymphatic mapping in patients with Stage I or II malignant melanoma.

Fluorescein: 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.
Overall Number of Participants Analyzed 90
Measure Type: Count of Participants
Unit of Measure: Participants
Adverse Event Recorded
5
   5.6%
Adverse Events Related to Study Treatment
0
   0.0%
Time Frame 1 month
Adverse Event Reporting Description All Adverse Events are reported - none were considered related to the investigational product.
 
Arm/Group Title Phase I/II Patients
Hide Arm/Group Description Fluorescein: 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.
All-Cause Mortality
Phase I/II Patients
Affected / at Risk (%)
Total   5/90 (5.56%)    
Hide Serious Adverse Events
Phase I/II Patients
Affected / at Risk (%) # Events
Total   1/90 (1.11%)    
General disorders   
hematoma, scalp pain †  1/90 (1.11%)  1
†
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Phase I/II Patients
Affected / at Risk (%) # Events
Total   5/90 (5.56%)    
Gastrointestinal disorders   
constipation †  1/90 (1.11%)  1
Infections and infestations   
wound infection †  1/90 (1.11%)  1
Metabolism and nutrition disorders   
hyperglycemia †  1/90 (1.11%)  1
hypoglycemia †  1/90 (1.11%)  1
Nervous system disorders   
neurophathic pain †  1/90 (1.11%)  1
amnesia †  1/90 (1.11%)  1
†
Indicates events were collected by systematic assessment
[Not Specified]
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Mark Wade
Organization: Huntsman Cancer Institute
Phone: 8012135746
EMail: mark.wade@hci.utah.edu
Layout table for additonal information
Responsible Party: University of Utah
ClinicalTrials.gov Identifier: NCT00847522    
Other Study ID Numbers: HCI26818
First Submitted: February 17, 2009
First Posted: February 19, 2009
Results First Submitted: June 30, 2017
Results First Posted: December 20, 2017
Last Update Posted: December 20, 2017