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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2013-01052 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| I 231512 | Other Identifier | Roswell Park Cancer Institute | |
| P30CA016056 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
PRIMARY OBJECTIVES:
I. To determine the feasibility of performing intravital microscopy on accessible human melanoma tumors during their standard course of treatment (i.e., wide local excision). (Part I)
SECONDARY OBJECTIVES:
I. To determine the blood flow velocity of the tumor vessels and tissue penetration of fluorescein (fluorescein sodium) as a marker of tumor vessel permeability. (Part II)
OUTLINE:
Patients receive fluorescein sodium intravenously (IV) followed by intravital microscopic observation over 10-15 minutes during excision of the melanoma.
After completion of study treatment, patients are followed up at 3 weeks and then periodically for 5 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diagnosis (intravital microscopy) | Experimental | Patients receive fluorescein sodium IV followed by intravital microscopic observation over 10-15 minutes during excision of the melanoma. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diagnostic Microscopy | Procedure | Undergo intravital microscopy |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Successful Intravital Microscopy on Accessible Human Melanoma Tumors During Standard Local Excision | 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. | Up to 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| "Percentage of Participants With Any Adverse Event | Percentage of participants with any adverse event. Described using upper one-sided 95% Clopper Pearson confidence limits. | Up to 5 years |
| Blood Flow Rates |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joseph Skitzki | Roswell Park Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Roswell Park Cancer Institute | Buffalo | New York | 14263 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Fluorescein Sodium Injection |
| Drug |
Given IV |
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| Laboratory Biomarker Analysis | Other | Correlative studies |
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| Therapeutic Conventional Surgery | Procedure | Undergo surgery |
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Sample tumor characteristics obtained from the intervention will be characterized using descriptive statistics (mean, medians) and 95% confidence intervals.
| Up to 2 months |
| Complication Rate | 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. | Up to 5 years |
| Median Overall Survival | Assessed using Kaplan Meier and Proportional Hazards methods. Collected through routine follow-up processes. | Up to 5 years |
| Median Progression Free Survival | Assessed using Kaplan Meier and Proportional Hazards methods. Collected through routine follow-up processes. | Up to 5 years |
| Percentage of Participants With Treatment Response | Treatment response was based upon the presence of a recurrence of the melanoma at either primary or metastatic sites. | Up to 5 years |
| Tumor Vasculature | Sample tumor characteristics obtained from the intervention will be characterized using descriptive statistics (mean, medians) and 95% confidence intervals. | Up to 2 months |
| COMPLETED |
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| NOT COMPLETED |
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All treated and eligible patients
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With Successful Intravital Microscopy on Accessible Human Melanoma Tumors During Standard Local Excision | 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. | All treated and eligible patients | Posted | Number | 95% Confidence Interval | percentage of participants | Up to 2 months |
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| Secondary | "Percentage of Participants With Any Adverse Event | Percentage of participants with any adverse event. Described using upper one-sided 95% Clopper Pearson confidence limits. | All treated and eligible patients. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to 5 years |
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| Secondary | Blood Flow Rates | Sample tumor characteristics obtained from the intervention will be characterized using descriptive statistics (mean, medians) and 95% confidence intervals. | 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. | Posted | Mean | 95% Confidence Interval | micrometers per second | Up to 2 months |
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| Secondary | Complication Rate | 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. | All treated and eligible patients | Posted | Count of Participants | Participants | Up to 5 years |
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| Secondary | Median Overall Survival | Assessed using Kaplan Meier and Proportional Hazards methods. Collected through routine follow-up processes. | All treated and eligible patients | Posted | Median | 95% Confidence Interval | months | Up to 5 years |
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| Secondary | Median Progression Free Survival | Assessed using Kaplan Meier and Proportional Hazards methods. Collected through routine follow-up processes. | All treated and eligible patients | Posted | Median | 95% Confidence Interval | months | Up to 5 years |
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| Secondary | Percentage of Participants With Treatment Response | Treatment response was based upon the presence of a recurrence of the melanoma at either primary or metastatic sites. | All treated and eligible patients | Posted | Number | 95% Confidence Interval | percentage of participants | Up to 5 years |
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| Secondary | Tumor Vasculature | Sample tumor characteristics obtained from the intervention will be characterized using descriptive statistics (mean, medians) and 95% confidence intervals. | Stringent dosing requirements precluded assessment of tumor vasculature endpoints. These measurements will be addressed in future studies. | Posted | Up to 2 months |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 | 1 | 10 | 4 | 10 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | Systematic Assessment |
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| Sinus bradycardia | Cardiac disorders | Systematic Assessment |
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| Oedema peripheral | General disorders | Systematic Assessment |
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| Pyrexia | General disorders | Systematic Assessment |
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| Skin infection | Infections and infestations | Systematic Assessment |
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| Incision site pain | Injury, poisoning and procedural complications | Systematic Assessment |
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| Wound dehiscence | Injury, poisoning and procedural complications | Systematic Assessment |
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| Alanine aminotransferase increased | Investigations | Systematic Assessment |
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| Aspartate aminotransferase increased | Investigations | Systematic Assessment |
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| Blood alkaline phosphatase increased | Investigations | Systematic Assessment |
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| Blood magnesium increased | Investigations | Systematic Assessment |
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| Blood potassium decreased | Investigations | Systematic Assessment |
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| Blood sodium decreased | Investigations | Systematic Assessment |
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| Troponin increased | Investigations | Systematic Assessment |
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| Hypoalbuminaemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Hypocalcaemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Joint range of motion decreased | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Insomnia | Psychiatric disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Administrator, Compliance - Clinical Research Services | Roswell Park Cancer Institute | 716-845-2300 |
| ID | Term |
|---|---|
| D008545 | Melanoma |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D019793 | Fluorescein |
| ID | Term |
|---|---|
| D005452 | Fluoresceins |
| D013141 | Spiro Compounds |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D014966 | Xanthenes |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D011083 | Polycyclic Compounds |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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