Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Rare Diseases

Melanoma

Melanoma, Cutaneous Malignant

Skin Neoplasms

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Diseases

Neuroendocrine Tumor

Neuroepithelioma

Patients receive indocyanine green and fluorescein sodium injection IV and then undergo intravital microscopic observation over 15-20 minutes during standard of care sentinel node biopsy.

Diagnostic Microscopy

Fluorescein Sodium Injection

Laboratory Biomarker Analysis

Undergo standard of care sentinel node biopsy

Sentinel Lymph Node Biopsy

Joseph Skitzki

This pilot clinical trial studies intravital microscopy in identifying tumor vessels in patients with stage IB-IIIC melanoma undergoing sentinel lymph node biopsy. By examining sentinel lymph nodes through intravital microscopy before they are removed, doctors may learn specific information regarding how melanoma may spread to lymph nodes and other sites of the body.

PRIMARY OBJECTIVES:

I. To determine the feasibility of intravital microscopy in characterizing the microvasculature of the sentinel lymph node (SLN) in melanoma patients requiring SLN biopsy.

SECONDARY OBJECTIVES:

I. To identify vascular blood flow parameters and flow kinetics associated with the sentinel lymph node vasculature and define the utility of using commonly used fluorescent agents during human intravital microscopy and correlate with clinical outcomes (time to recurrence, survival), as a potential basis for a novel prognostic tool and/or microstaging technique.

TERTIARY OBJECTIVES:

I. To determine the relationship between live microscopically-recorded images and pathology slides in terms of vessel density and vessel diameter.

OUTLINE:

Patients receive indocyanine green and fluorescein sodium injection intravenously (IV) and then undergo intravital microscopic observation over 15-20 minutes during standard of care sentinel node biopsy.

After completion of study treatment, patients are followed up at 3 weeks and then every 6 months for 5 years or every 3 months for 2 years and every 6 months for another 2 years.

Intravital Microscopy in Identifying Tumor Vessels in Patients With Stage IB-IIIC Melanoma Undergoing Sentinel Lymph Node Biopsy

Intravital Microscopy (IVM) During Sentinel Lymph Node (SLN) Biopsy for Melanoma

The relationship between the live microscopically-recorded images and the pathology slides in terms of vessel density and vessel diameter will be determined. Correlations between microscopic observations (vessel diameter, density, blood flow velocity, vessel hierarchy tissue penetration of fluorescein/indocyanine green) with pathologic node positivity and clinical outcomes (time to recurrence, survival) will be analyzed.

The visualization method will be deemed successful in patients with tumor vessel identification, measurement of tumor vessel diameters, determining vessel density, and visualizing fluorescein/indocyanine green within the tumor vessels.

Sample sentinel lymph node characteristics obtained from the intervention will be characterized using descriptive statistics (means, medians) and 95% confidence intervals.

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

Assessed using Logistic Regression. Collected through routine follow-up processes.

Roswell Park Cancer Institute

Digestive System Diseases

Gland and Hormone Related Diseases

Nervous System Diseases

Carcinoma

Stomach Neoplasms

Pancreatic Neoplasms

Carcinoma, Ductal

Sarcoma

Brain Neoplasms

Colorectal Neoplasms

Neoplasms, Glandular and Epithelial

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Neoplasms, Connective and Soft Tissue

Stomach Diseases

Central Nervous System Neoplasms

Nervous System Neoplasms

Brain Diseases

Central Nervous System Diseases

Endocrine Gland Neoplasms

Pancreatic Diseases

Endocrine System Diseases

Stomach Cancer

Pancreatic Cancer

Bile Duct Cancer

Soft Tissue Sarcoma

Intrahepatic Cholangiocarcinoma

Determine the feasibility and clinical utility of performing Human Intravital Microscopy (HIVM) in patients with solid tumors during surgical resection.

Undergo Intravital microscopy (IVM), which allows real-time, direct visualization of microscopic blood vessels and calculation of blood flow.

Emmanuel M Gabriel, M.D., Ph.D.

This study will investigate the tumor-associated vasculature of patients with solid tumors. The investigators will use a technology known as intravital microscopy (IVM) in order to visualize in real-time the vessels associated with solid tumors. The IVM observations may determine if an individual patient's tumor vessels would be amenable to receiving systemic therapy, based on the functionality of the vessels.

PRIMARY OBJECTIVE: To determine the feasibility and clinical utility of performing HIVM in patients with solid tumors during standard course of treatment (surgical resection).

SECONDARY OBJECTIVES:

1. Compare the microscopic observation of the tumor-associated vessels with normal tissue (e.g. peritoneal surface or normal brain tissue) in each individual subject.
2. Correlate the microscopic observations of the tumor-associated vessels with pathologic grade of tumor.
3. To correlate the microscopic observation of the microvasculature with tumor-specific and overall survival.

OUTLINE:

Patients receive fluorescein intravenously (IV) and undergo HIVM over 1-2 minutes per field.

After completion of study, patients are followed up at 2-3 weeks after surgery.

This is an open-label, non-randomized, single center, study of IVM observation in conjunction with fluorescein in subjects with solid tumors undergoing surgical resection.

Intravital Microscopy in Human Solid Tumors

Intravital Microscopy (IVM) in Human Solid Tumors

Identify and measure vessels associated with solid tumors

Visualize vital dye within the vessels (fluorescein)

Calculate the blood flow velocity of the vessels and tissue penetration of fluorescent dye as a marker of vessel permeability.

Post-operative comparison of the microvasculature of tumor with normal tissue (e.g. peritoneum) in each individual subject using vessel diameters, vessel density, detection of intravital dye and flow rates.

The investigators will determine if there is a correlation between the microvasculature with pathologic features of the tumor implants (i.e. tumor grade) at the time of the final pathology report (5-7 days after surgery).

The investigators will determine if there is a correlation between the microscopic observation of the tumor microvasculature tumor-specific and overall survival.

Mayo Clinic

Principal Investigator

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Gonadal Disorders

Ovarian Cancer

Ovarian Epithelial Cancer

Fallopian Tube Cancer

Patients receive fluorescein sodium injection IV. Patients also undergo observation of primary and metastatic tumors via microscopy over 15-20 minutes during the course of standard of care surgery.

Undergo observation via intravital microscopy

Emese Zsiros, MD

This pilot clinical trial studies how well intravital microscopy works in evaluating patients with primary peritoneal, fallopian tube, or stage IA-IV ovarian cancer. Intravital microscopic evaluation of tumor blood vessels, blood flow, immune cell interactions, and drug uptake may be eventually visualized and may lead to valuable prognostic information.

PRIMARY OBJECTIVES:

I. To determine the feasibility of performing intravital microscopy on accessible human ovarian, primary peritoneal and fallopian tube cancers during their standard course of treatment (i.e., surgical debulking).

SECONDARY OBJECTIVES:

I. To determine the blood flow velocity of the tumor vessels and tissue penetration of fluorescein as a marker of tumor vessel permeability.

OUTLINE:

Patients receive fluorescein sodium injection intravenously (IV). Patients also undergo observation of primary and metastatic tumors via microscopy over 15-20 minutes during the course of standard of care surgery.

After completion of study, patients are followed up for 30 days, at 1-3 weeks, and then up to 2 years.

Intravital Microscopy in Evaluating Patients With Primary Peritoneal, Fallopian Tube, or Stage IA-IV Ovarian Cancer

A Pilot Study of Feasibility of Performing Intravital Microscopy in Patients With Ovarian, Primary Peritoneal or Fallopian Tube Cancer

Will visualize fluorescein within the tumor vessels.

Will determine vessel density per 10 x field.

Will assess the ability to measure the blood flow velocity of the tumor vessels.

Will measure tissue penetration of fluorescein as a marker of tumor vessel permeability.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Intravital Microscopy in Identifying Tumor Vessels in Patients With Stage IB-IIIC Melanoma Undergoing Sentinel Lymph Node Biopsy	NCT02857374	Stage IB Skin M... Stage IIA Skin ... Stage IIB Skin ... Stage IIC Skin ... Stage IIIA Skin... Stage IIIB Skin... Stage IIIC Skin...	Diagnostic Micr... Fluorescein Sod... Laboratory Biom... Sentinel Lymph ...	18 Years -	Roswell Park Cancer Institute
Intravital Microscopy in Human Solid Tumors	NCT03823144	Solid Tumor, Ad... Clinical Stage ... Gastric Carcino... Malignant Solid... Metastatic Colo... Metastatic Gast... Metastatic Prim... Metastatic Sarc... Postneoadjuvant... Resectable Colo... Resectable Live... Resectable Panc... Resectable Sarc... Stage IV Colore...	Diagnostic Micr... Fluorescein Sod...	18 Years -	Mayo Clinic
Intravital Microscopy in Evaluating Patients With Primary Peritoneal, Fallopian Tube, or Stage IA-IV Ovarian Cancer	NCT03297489	Fallopian Tube ... Primary Periton... Stage I Ovarian... Stage IA Ovaria... Stage IB Ovaria... Stage IC Ovaria... Stage II Ovaria... Stage IIA Ovari... Stage IIB Ovari... Stage IIC Ovari... Stage III Ovari... Stage IIIA Ovar... Stage IIIB Ovar... Stage IIIC Ovar... Stage IV Ovaria...	Diagnostic Micr... Fluorescein Sod... Laboratory Biom...	18 Years -	Roswell Park Cancer Institute
Intravital Microscopy in Human Solid Tumors	NCT03823144	Solid Tumor, Ad... Clinical Stage ... Gastric Carcino... Malignant Solid... Metastatic Colo... Metastatic Gast... Metastatic Prim... Metastatic Sarc... Postneoadjuvant... Resectable Colo... Resectable Live... Resectable Panc... Resectable Sarc... Stage IV Colore...	Diagnostic Micr... Fluorescein Sod...	18 Years -	Mayo Clinic
Intravital Microscopy in Evaluating Patients With Primary Peritoneal, Fallopian Tube, or Stage IA-IV Ovarian Cancer	NCT03297489	Fallopian Tube ... Primary Periton... Stage I Ovarian... Stage IA Ovaria... Stage IB Ovaria... Stage IC Ovaria... Stage II Ovaria... Stage IIA Ovari... Stage IIB Ovari... Stage IIC Ovari... Stage III Ovari... Stage IIIA Ovar... Stage IIIB Ovar... Stage IIIC Ovar... Stage IV Ovaria...	Diagnostic Micr... Fluorescein Sod... Laboratory Biom...	18 Years -	Roswell Park Cancer Institute

Spots Global Cancer Trial Database for fluorescein sodium injection