Trial Outcomes & Findings for Intravital Microscopy for Identifying Tumor Vessels in Patients With Stage IA-IV Melanoma That is Being Removed by Surgery (NCT NCT01886235)

Last Updated: 2020-08-07

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

10 participants

Primary outcome timeframe

Up to 2 months

Results posted on

2020-08-07

Participant Flow

Participant milestones

Participant milestones
Measure	Diagnosis (Intravital Microscopy) 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 Study STARTED	10
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Diagnosis (Intravital Microscopy) n=10 Participants 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
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants
Age, Continuous	58.5 years STANDARD_DEVIATION 10.6 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	10 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 2 months

Population: All treated and eligible patients

Outcome measures

Outcome measures
Measure	Diagnosis (Intravital Microscopy) n=10 Participants 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
Percentage of Participants With Successful Intravital Microscopy on Accessible Human Melanoma Tumors During Standard Local Excision	70 percentage of participants Interval 39.4 to 90.7

SECONDARY outcome

Timeframe: Up to 5 years

Population: All treated and eligible patients.

Percentage of participants with any adverse event. Described using upper one-sided 95% Clopper Pearson confidence limits.

Outcome measures

Outcome measures
Measure	Diagnosis (Intravital Microscopy) n=10 Participants 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
"Percentage of Participants With Any Adverse Event	40 percentage of participants Interval 9.6 to 70.4

SECONDARY outcome

Timeframe: Up to 2 months

Population: 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.

Sample tumor characteristics obtained from the intervention will be characterized using descriptive statistics (mean, medians) and 95% confidence intervals.

Outcome measures

Outcome measures
Measure	Diagnosis (Intravital Microscopy) n=7 Participants 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
Blood Flow Rates	270 micrometers per second Interval 206.0 to 334.0

SECONDARY outcome

Timeframe: Up to 5 years

Population: All treated and eligible patients

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.

Outcome measures

Outcome measures
Measure	Diagnosis (Intravital Microscopy) n=10 Participants 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
Complication Rate	0 Participants

SECONDARY outcome

Timeframe: Up to 5 years

Population: All treated and eligible patients

Assessed using Kaplan Meier and Proportional Hazards methods. Collected through routine follow-up processes.

Outcome measures

Outcome measures
Measure	Diagnosis (Intravital Microscopy) n=10 Participants 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
Median Overall Survival	NA months Interval 13.9 to the median and upper confidence limit were not reached

SECONDARY outcome

Timeframe: Up to 5 years

Population: All treated and eligible patients

Assessed using Kaplan Meier and Proportional Hazards methods. Collected through routine follow-up processes.

Outcome measures

Outcome measures
Measure	Diagnosis (Intravital Microscopy) n=10 Participants 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
Median Progression Free Survival	NA months Interval 13.9 to The median and upper confidence limit were not reached.

SECONDARY outcome

Timeframe: Up to 5 years

Population: All treated and eligible patients

Treatment response was based upon the presence of a recurrence of the melanoma at either primary or metastatic sites.

Outcome measures

Outcome measures
Measure	Diagnosis (Intravital Microscopy) n=10 Participants 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
Percentage of Participants With Treatment Response	0 percentage of participants Interval 0.0 to 31.0

SECONDARY outcome

Timeframe: Up to 2 months

Population: Stringent dosing requirements precluded assessment of tumor vasculature endpoints. These measurements will be addressed in future studies.

Sample tumor characteristics obtained from the intervention will be characterized using descriptive statistics (mean, medians) and 95% confidence intervals.

Outcome measures

Outcome data not reported

Adverse Events

Diagnosis (Intravital Microscopy)

Serious events: 1 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Diagnosis (Intravital Microscopy) n=10 participants at risk 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
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	10.0% 1/10 • Number of events 1

Other adverse events

Other adverse events
Measure	Diagnosis (Intravital Microscopy) n=10 participants at risk 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
Blood and lymphatic system disorders Anaemia	10.0% 1/10 • Number of events 3
Cardiac disorders Sinus bradycardia	10.0% 1/10 • Number of events 1
General disorders Oedema peripheral	10.0% 1/10 • Number of events 1
General disorders Pyrexia	10.0% 1/10 • Number of events 2
Infections and infestations Skin infection	10.0% 1/10 • Number of events 2
Injury, poisoning and procedural complications Incision site pain	10.0% 1/10 • Number of events 1
Injury, poisoning and procedural complications Wound dehiscence	10.0% 1/10 • Number of events 1
Investigations Alanine aminotransferase increased	10.0% 1/10 • Number of events 1
Investigations Aspartate aminotransferase increased	10.0% 1/10 • Number of events 1
Investigations Blood alkaline phosphatase increased	10.0% 1/10 • Number of events 1
Investigations Blood magnesium increased	10.0% 1/10 • Number of events 1
Investigations Blood potassium decreased	10.0% 1/10 • Number of events 1
Investigations Blood sodium decreased	10.0% 1/10 • Number of events 1
Investigations Troponin increased	10.0% 1/10 • Number of events 1
Metabolism and nutrition disorders Hypoalbuminaemia	10.0% 1/10 • Number of events 1
Metabolism and nutrition disorders Hypocalcaemia	10.0% 1/10 • Number of events 1
Musculoskeletal and connective tissue disorders Joint range of motion decreased	10.0% 1/10 • Number of events 1
Psychiatric disorders Insomnia	10.0% 1/10 • Number of events 1

Additional Information

Senior Administrator, Compliance - Clinical Research Services

Roswell Park Cancer Institute

Phone: 716-845-2300

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place