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

• 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: Roswell Park Cancer Institute
• 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

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	Diagnosis (Intravital Microscopy)
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

Baseline Characteristics

Arm/Group Title		Diagnosis (Intravital Microscopy)
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
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%

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants With Successful Intravital Microscopy on Accessible Human Melanoma Tumors During Standard Local Excision
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

Outcome Measure Data

Analysis Population Description

All treated and eligible patients

Arm/Group Title	Diagnosis (Intravital Microscopy)
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
Description	Percentage of participants with any adverse event. Described using upper one-sided 95% Clopper Pearson confidence limits.
Time Frame	Up to 5 years

Outcome Measure Data

Analysis Population Description

All treated and eligible patients.

Arm/Group Title	Diagnosis (Intravital Microscopy)
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
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

Outcome Measure Data

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)
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
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

Outcome Measure Data

Analysis Population Description

All treated and eligible patients

Arm/Group Title	Diagnosis (Intravital Microscopy)
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
Description	Assessed using Kaplan Meier and Proportional Hazards methods. Collected through routine follow-up processes.
Time Frame	Up to 5 years

Outcome Measure Data

Analysis Population Description

All treated and eligible patients

Arm/Group Title	Diagnosis (Intravital Microscopy)
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
Description	Assessed using Kaplan Meier and Proportional Hazards methods. Collected through routine follow-up processes.
Time Frame	Up to 5 years

Outcome Measure Data

Analysis Population Description

All treated and eligible patients

Arm/Group Title	Diagnosis (Intravital Microscopy)
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
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

Outcome Measure Data

Analysis Population Description

All treated and eligible patients

Arm/Group Title	Diagnosis (Intravital Microscopy)
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
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

Outcome Measure Data

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)
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.

Adverse Events

Time Frame	[Not Specified]
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Diagnosis (Intravital Microscopy)
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	--/--
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
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

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact

• Name/Title: Senior Administrator, Compliance - Clinical Research Services
• Organization: Roswell Park Cancer Institute
• Phone: 716-845-2300

• 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