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NCT Number: NCT03823144

Intravital Microscopy in Human Solid Tumors

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.

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Key information

Conditions

Solid Tumor, Adult Adenocarcinoma Anatomic Stage IV Breast Cancer AJCC v8 Brain Diseases Brain Neoplasms Breast Diseases Breast Neoplasms Carcinoma Carcinoma, Hepatocellular Central Nervous System Diseases Central Nervous System Neoplasms Cholangiocarcinoma Clinical Stage IV Gastric Cancer AJCC v8 Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Liver Diseases Liver Neoplasms Malignant Brain Neoplasm Malignant Solid Neoplasm Metastatic Breast Carcinoma Metastatic Colorectal Carcinoma Metastatic Gastric Carcinoma Metastatic Liver Carcinoma Metastatic Pancreatic Carcinoma Metastatic Primary Malignant Brain Neoplasm Metastatic Sarcoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Connective and Soft Tissue Neoplasms, Glandular and Epithelial Nervous System Diseases Nervous System Neoplasms Pancreatic Diseases Pancreatic Neoplasms Postneoadjuvant Therapy Stage IV Gastric Cancer AJCC v8 Rectal Diseases Resectable Brain Neoplasm Resectable Breast Carcinoma Resectable Colorectal Carcinoma Resectable Gastric Carcinoma Resectable Liver and Intrahepatic Bile Duct Carcinoma Resectable Pancreatic Carcinoma Resectable Sarcoma Sarcoma Skin Diseases Skin and Connective Tissue Diseases Stage IV Colorectal Cancer AJCC v8 Stage IV Hepatocellular Carcinoma AJCC v8 Stage IV Pancreatic Cancer AJCC v8 Stomach Diseases Stomach Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic Florida

Jacksonville, Florida, 32224, United States

Location status: Recruiting

Location contact

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

CONTACT

[email protected]

904-953-2523

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

PRINCIPAL_INVESTIGATOR

Michael B Wallace, M.D.

SUB_INVESTIGATOR

About this study

PRIMARY OBJECTIVE:

I. To determine the feasibility of performing human intravital microscopy (HIVM) in patients with deep space solid tumors during standard course of surgical resection.

SECONDARY OBJECTIVES:

I. Compare the microscopic observation of the tumor-associated vessels with normal tissue (e.g. peritoneal surface or normal brain tissue) in each individual subject.

II. Correlate the microscopic observations of the tumor-associated vessels with pathologic grade of tumor.

III. 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 18 years of age
  • Eastern Cooperative Oncology Group (ECOG)Performance Status of ≤ 2
  • Measurable tumor by direct visualization requiring surgical resection in the operating room (OR)
  • Tumor types of origin include gastric, pancreatic, hepatobiliary, colorectal, sarcoma, brain, or breast cancer that may involve the axillary lymph nodes cancers. Tumors may be primary or metastatic
  • Subject must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent
  • Subject must have a skin prick test pre-operatively (at the time of the preoperative visit and after signed informed consent for entry into this clinical trial is given) to determine any sensitivity to fluorescein

Exclusion criteria

  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations
  • Renal dysfunction as defined as a glomerular filtration rate (GFR) < 45
  • Liver dysfunction as defined by Child-Pugh score > 5, or liver function test (LFT)'s 1.5 x above normal range
  • Any known allergy or prior reaction to fluorescein or a positive skin prick test to fluorescein
  • Pregnant or nursing female subjects, determined preoperatively with a urine pregnancy test
  • Unwilling or unable to follow protocol requirements
  • Any condition which in the investigators' opinion deems the patient unsuitable (e.g., abnormal electrocardiography [EKG], including T wave inversion, elevated T waves, prolonged QRS interval, or conduction blocks) or that requires further work-up (including cardiac echo or stress test)
  • Any condition that excludes surgical resection as the standard of care for the patient

Treatment and study plan

Diagnostic Microscopy

Device

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

Other names: Human Intravital Microscopy, IVM, HIVM

Fluorescein Sodium Injection

Drug

Given IV as part of IVM procedure

Other names: AK-Fluor, Fluorescite

Primary outcomes

  1. 1. Tumor vessel identification (# tumor vessels visualized per high power field)

    Time frame: 12-15 minutes

    Identify and measure vessels associated with solid tumors

  2. 2. Tumor vessel density (# tumor vessels per square cm area observed)

    Time frame: 12-15 minutes

    Determine vessel density per 10x field

  3. 3. Fluorescent dye uptake (# tumor vessels with fluorescent dye uptake and # tumor vessels without dye uptake)

    Time frame: 12-15 minutes

    Visualize vital dye within the vessels (fluorescein)

  4. 4. Tumor blood flow (velocity, mm/sec)

    Time frame: 12-15 minutes

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

Secondary outcomes

  1. 5. Post-operative comparison of the microvasculature of tumor with normal tissue

    Time frame: 15-20 minutes

    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.

  2. 6. Post-operative correlation of 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).

    Time frame: 5-7 days

    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).

  3. Post-operative correlation of the microscopic observation of the tumor microvasculature tumor-specific and overall survival.

    Time frame: 5 years

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

Study contacts

Contact information is provided by the study sponsor or research team.

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

CONTACT

[email protected]

904-953-2523

Michael B Wallace, M.D.

CONTACT

[email protected]

904-953-2221

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

Intravital Microscopy (IVM) in Human Solid Tumors

Important dates

Study start
2019
Primary completion
2027
Study completion
2027
First posted
Jan 30, 2019
Registry last updated
Jun 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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