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Intravital Microscopy for Identifying Tumor Vessels in Patients With Stage IA-IV Melanoma That is Being Removed by Surgery

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ClinicalTrials.gov Identifier: NCT01886235
Recruitment Status : Completed
First Posted : June 25, 2013
Results First Posted : June 6, 2017
Last Update Posted : August 7, 2020
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Roswell Park Cancer Institute

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Conditions Recurrent Melanoma
Stage IA Skin Melanoma
Stage IB Skin Melanoma
Stage IIA Skin Melanoma
Stage IIB Skin Melanoma
Stage IIC Skin Melanoma
Stage IIIA Skin Melanoma
Stage IIIB Skin Melanoma
Stage IIIC Skin Melanoma
Stage IV Skin Melanoma
Interventions Procedure: Diagnostic Microscopy
Drug: Fluorescein Sodium Injection
Other: Laboratory Biomarker Analysis
Procedure: Therapeutic Conventional Surgery
Enrollment 10
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Diagnosis (Intravital Microscopy)
Hide Arm/Group Description

Patients receive fluorescein sodium IV followed by intravital microscopic observation over 10-15 minutes during excision of the melanoma.

Diagnostic Microscopy: Undergo intravital microscopy

Fluorescein Sodium Injection: Given IV

Laboratory Biomarker Analysis: Correlative studies

Therapeutic Conventional Surgery: Undergo surgery

Period Title: Overall Study
Started 10
Completed 10
Not Completed 0
Arm/Group Title Diagnosis (Intravital Microscopy)
Hide Arm/Group Description

Patients receive fluorescein sodium IV followed by intravital microscopic observation over 10-15 minutes during excision of the melanoma.

Diagnostic Microscopy: Undergo intravital microscopy

Fluorescein Sodium Injection: Given IV

Laboratory Biomarker Analysis: Correlative studies

Therapeutic Conventional Surgery: Undergo surgery

Overall Number of Baseline Participants 10
Hide Baseline Analysis Population Description
All treated and eligible patients
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
<=18 years
0
   0.0%
Between 18 and 65 years
8
  80.0%
>=65 years
2
  20.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 10 participants
58.5  (10.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
Female
5
  50.0%
Male
5
  50.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
10
 100.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
1.Primary Outcome
Title Percentage of Participants With Successful Intravital Microscopy on Accessible Human Melanoma Tumors During Standard Local Excision
Hide Description A successful intravital microscopic observation will include the ability to identify tumor vessels, measure tumor vessel diameters, determine vessel density per 10 x field and visualize fluorescein within the tumor vessels.
Time Frame Up to 2 months
Hide Outcome Measure Data
Hide Analysis Population Description
All treated and eligible patients
Arm/Group Title Diagnosis (Intravital Microscopy)
Hide Arm/Group Description:

Patients receive fluorescein sodium IV followed by intravital microscopic observation over 10-15 minutes during excision of the melanoma.

Diagnostic Microscopy: Undergo intravital microscopy

Fluorescein Sodium Injection: Given IV

Laboratory Biomarker Analysis: Correlative studies

Therapeutic Conventional Surgery: Undergo surgery

Overall Number of Participants Analyzed 10
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
70
(39.4 to 90.7)
2.Secondary Outcome
Title "Percentage of Participants With Any Adverse Event
Hide Description Percentage of participants with any adverse event. Described using upper one-sided 95% Clopper Pearson confidence limits.
Time Frame Up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
All treated and eligible patients.
Arm/Group Title Diagnosis (Intravital Microscopy)
Hide Arm/Group Description:

Patients receive fluorescein sodium IV followed by intravital microscopic observation over 10-15 minutes during excision of the melanoma.

Diagnostic Microscopy: Undergo intravital microscopy

Fluorescein Sodium Injection: Given IV

Laboratory Biomarker Analysis: Correlative studies

Therapeutic Conventional Surgery: Undergo surgery

Overall Number of Participants Analyzed 10
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
40
(9.6 to 70.4)
3.Secondary Outcome
Title Blood Flow Rates
Hide Description Sample tumor characteristics obtained from the intervention will be characterized using descriptive statistics (mean, medians) and 95% confidence intervals.
Time Frame Up to 2 months
Hide Outcome Measure Data
Hide Analysis Population Description
All treated and evaluable patients. Only 7 patients had data available, one patient had an unobservable tumor and two patients the fluorscein never made it to the tumor.
Arm/Group Title Diagnosis (Intravital Microscopy)
Hide Arm/Group Description:

Patients receive fluorescein sodium IV followed by intravital microscopic observation over 10-15 minutes during excision of the melanoma.

Diagnostic Microscopy: Undergo intravital microscopy

Fluorescein Sodium Injection: Given IV

Laboratory Biomarker Analysis: Correlative studies

Therapeutic Conventional Surgery: Undergo surgery

Overall Number of Participants Analyzed 7
Mean (95% Confidence Interval)
Unit of Measure: micrometers per second
270
(206 to 334)
4.Secondary Outcome
Title Complication Rate
Hide Description Number of participants with an event that would disrupt the standard surgical procedure or create an adverse event that would not be anticipated from the standard surgery.
Time Frame Up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
All treated and eligible patients
Arm/Group Title Diagnosis (Intravital Microscopy)
Hide Arm/Group Description:

Patients receive fluorescein sodium IV followed by intravital microscopic observation over 10-15 minutes during excision of the melanoma.

Diagnostic Microscopy: Undergo intravital microscopy

Fluorescein Sodium Injection: Given IV

Laboratory Biomarker Analysis: Correlative studies

Therapeutic Conventional Surgery: Undergo surgery

Overall Number of Participants Analyzed 10
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
5.Secondary Outcome
Title Median Overall Survival
Hide Description Assessed using Kaplan Meier and Proportional Hazards methods. Collected through routine follow-up processes.
Time Frame Up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
All treated and eligible patients
Arm/Group Title Diagnosis (Intravital Microscopy)
Hide Arm/Group Description:

Patients receive fluorescein sodium IV followed by intravital microscopic observation over 10-15 minutes during excision of the melanoma.

Diagnostic Microscopy: Undergo intravital microscopy

Fluorescein Sodium Injection: Given IV

Laboratory Biomarker Analysis: Correlative studies

Therapeutic Conventional Surgery: Undergo surgery

Overall Number of Participants Analyzed 10
Median (95% Confidence Interval)
Unit of Measure: months
NA [1] 
(13.9 to NA)
[1]
the median and upper confidence limit were not reached
6.Secondary Outcome
Title Median Progression Free Survival
Hide Description Assessed using Kaplan Meier and Proportional Hazards methods. Collected through routine follow-up processes.
Time Frame Up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
All treated and eligible patients
Arm/Group Title Diagnosis (Intravital Microscopy)
Hide Arm/Group Description:

Patients receive fluorescein sodium IV followed by intravital microscopic observation over 10-15 minutes during excision of the melanoma.

Diagnostic Microscopy: Undergo intravital microscopy

Fluorescein Sodium Injection: Given IV

Laboratory Biomarker Analysis: Correlative studies

Therapeutic Conventional Surgery: Undergo surgery

Overall Number of Participants Analyzed 10
Median (95% Confidence Interval)
Unit of Measure: months
NA [1] 
(13.9 to NA)
[1]
The median and upper confidence limit were not reached.
7.Secondary Outcome
Title Percentage of Participants With Treatment Response
Hide Description Treatment response was based upon the presence of a recurrence of the melanoma at either primary or metastatic sites.
Time Frame Up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
All treated and eligible patients
Arm/Group Title Diagnosis (Intravital Microscopy)
Hide Arm/Group Description:

Patients receive fluorescein sodium IV followed by intravital microscopic observation over 10-15 minutes during excision of the melanoma.

Diagnostic Microscopy: Undergo intravital microscopy

Fluorescein Sodium Injection: Given IV

Laboratory Biomarker Analysis: Correlative studies

Therapeutic Conventional Surgery: Undergo surgery

Overall Number of Participants Analyzed 10
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
0
(0 to 31)
8.Secondary Outcome
Title Tumor Vasculature
Hide Description Sample tumor characteristics obtained from the intervention will be characterized using descriptive statistics (mean, medians) and 95% confidence intervals.
Time Frame Up to 2 months
Hide Outcome Measure Data
Hide Analysis Population Description
Stringent dosing requirements precluded assessment of tumor vasculature endpoints. These measurements will be addressed in future studies.
Arm/Group Title Diagnosis (Intravital Microscopy)
Hide Arm/Group Description:

Patients receive fluorescein sodium IV followed by intravital microscopic observation over 10-15 minutes during excision of the melanoma.

Diagnostic Microscopy: Undergo intravital microscopy

Fluorescein Sodium Injection: Given IV

Laboratory Biomarker Analysis: Correlative studies

Therapeutic Conventional Surgery: Undergo surgery

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Diagnosis (Intravital Microscopy)
Hide Arm/Group Description

Patients receive fluorescein sodium IV followed by intravital microscopic observation over 10-15 minutes during excision of the melanoma.

Diagnostic Microscopy: Undergo intravital microscopy

Fluorescein Sodium Injection: Given IV

Laboratory Biomarker Analysis: Correlative studies

Therapeutic Conventional Surgery: Undergo surgery

All-Cause Mortality
Diagnosis (Intravital Microscopy)
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
Diagnosis (Intravital Microscopy)
Affected / at Risk (%) # Events
Total   1/10 (10.00%)    
Respiratory, thoracic and mediastinal disorders   
Pneumonia aspiration   1/10 (10.00%)  1
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Diagnosis (Intravital Microscopy)
Affected / at Risk (%) # Events
Total   4/10 (40.00%)    
Blood and lymphatic system disorders   
Anaemia   1/10 (10.00%)  3
Cardiac disorders   
Sinus bradycardia   1/10 (10.00%)  1
General disorders   
Oedema peripheral   1/10 (10.00%)  1
Pyrexia   1/10 (10.00%)  2
Infections and infestations   
Skin infection   1/10 (10.00%)  2
Injury, poisoning and procedural complications   
Incision site pain   1/10 (10.00%)  1
Wound dehiscence   1/10 (10.00%)  1
Investigations   
Alanine aminotransferase increased   1/10 (10.00%)  1
Aspartate aminotransferase increased   1/10 (10.00%)  1
Blood alkaline phosphatase increased   1/10 (10.00%)  1
Blood magnesium increased   1/10 (10.00%)  1
Blood potassium decreased   1/10 (10.00%)  1
Blood sodium decreased   1/10 (10.00%)  1
Troponin increased   1/10 (10.00%)  1
Metabolism and nutrition disorders   
Hypoalbuminaemia   1/10 (10.00%)  1
Hypocalcaemia   1/10 (10.00%)  1
Musculoskeletal and connective tissue disorders   
Joint range of motion decreased   1/10 (10.00%)  1
Psychiatric disorders   
Insomnia   1/10 (10.00%)  1
Indicates events were collected by systematic assessment
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: Senior Administrator, Compliance - Clinical Research Services
Organization: Roswell Park Cancer Institute
Phone: 716-845-2300
Layout table for additonal information
Responsible Party: Roswell Park Cancer Institute
ClinicalTrials.gov Identifier: NCT01886235    
Other Study ID Numbers: I 231512
NCI-2013-01052 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
I 231512 ( Other Identifier: Roswell Park Cancer Institute )
P30CA016056 ( U.S. NIH Grant/Contract )
First Submitted: May 30, 2013
First Posted: June 25, 2013
Results First Submitted: March 30, 2017
Results First Posted: June 6, 2017
Last Update Posted: August 7, 2020