Intravital Microscopy in Human Solid Tumors

Not Applicable

Recruiting

• Conditions: Solid Tumor, Adult; Malignant Solid Neoplasm; Stage IV Colorectal Cancer AJCC v8; Clinical Stage IV Gastric Cancer AJCC v8; Metastatic Colorectal Carcinoma; Metastatic Primary Malignant Brain Neoplasm; Resectable Colorectal Carcinoma; Malignant Brain Neoplasm; Resectable Liver and Intrahepatic Bile Duct Carcinoma; Resectable Sarcoma
• Interventions: Device: Diagnostic Microscopy; Drug: Fluorescein Sodium Injection

• Registration Number: NCT03823144
• Lead Sponsor: Mayo Clinic

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2019-01-28
• Study First Submitted QC: 2019-01-28
• Study First Posted: 2019-01-30
• Study Start: 2019-02-28
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-01
• Last Update Posted: 2025-07-03
• Primary Completion: 2026-05-30
• Study Completion: 2026-05-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 85

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm 1	Fluorescein Sodium Injection	Determine the feasibility and clinical utility of performing Human Intravital Microscopy (HIVM) in patients with solid tumors during surgical resection.
Arm 1	Diagnostic Microscopy	Determine the feasibility and clinical utility of performing Human Intravital Microscopy (HIVM) in patients with solid tumors during surgical resection.

Primary Outcome Measures

Name	Time	Method
1. Tumor vessel identification (# tumor vessels visualized per high power field)	12-15 minutes	Identify and measure vessels associated with solid tumors
2. Tumor vessel density (# tumor vessels per square cm area observed)	12-15 minutes	Determine vessel density per 10x field
3. Fluorescent dye uptake (# tumor vessels with fluorescent dye uptake and # tumor vessels without dye uptake)	12-15 minutes	Visualize vital dye within the vessels (fluorescein)
4. Tumor blood flow (velocity, mm/sec)	12-15 minutes	Calculate the blood flow velocity of the vessels and tissue penetration of fluorescent dye as a marker of vessel permeability.

Secondary Outcome Measures

Name	Time	Method
5. Post-operative comparison of the microvasculature of tumor with normal tissue	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.
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).	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).
Post-operative correlation of the microscopic observation of the tumor microvasculature tumor-specific and overall survival.	5 years	The investigators will determine if there is a correlation between the microscopic observation of the tumor microvasculature tumor-specific and overall survival.

Trial Locations

Locations (1)

Mayo Clinic Florida; 🇺🇸 Jacksonville, Florida, United States