NCT03823144

Intravital Microscopy in Human Solid Tumors

Intravital Microscopy (IVM) in Human Solid Tumors

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 85 (estimated)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Solid Tumor, Adult
• Clinical Stage IV Gastric Cancer AJCC v8
• Malignant Solid Neoplasm
• Metastatic Colorectal Carcinoma
• Metastatic Gastric Carcinoma
• Metastatic Primary Malignant Brain Neoplasm
• Metastatic Sarcoma
• Postneoadjuvant Therapy Stage IV Gastric Cancer AJCC v8
• Resectable Colorectal Carcinoma
• Resectable Liver and Intrahepatic Bile Duct Carcinoma
• Resectable Pancreatic Carcinoma
• Resectable Sarcoma
• Stage IV Colorectal Cancer AJCC v8
• Anatomic Stage IV Breast Cancer AJCC v8
• Malignant Brain Neoplasm
• Metastatic Breast Carcinoma
• Metastatic Liver Carcinoma
• Metastatic Pancreatic Carcinoma
• Resectable Brain Neoplasm
• Resectable Breast Carcinoma
• Resectable Gastric Carcinoma
• Stage IV Hepatocellular Carcinoma AJCC v8
• Stage IV Pancreatic Cancer AJCC v8

Interventions

Type	Name	Description
DEVICE	Diagnostic Microscopy	Undergo Intravital microscopy (IVM), which allows real-time, direct visualization of microscopic blood vessels and calculation of blood flow.
DRUG	Fluorescein Sodium Injection	Given IV as part of IVM procedure

Timeline

• Start date: 2019-02-28
• Primary completion: 2026-09-30
• Completion: 2026-09-30
• First posted: 2019-01-30
• Last updated: 2025-12-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study