Intravital Microscopy in Human Solid Tumors

Mayo Clinic

Status: Enrolling

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

Treatments: Device: Diagnostic Microscopy; Drug: Fluorescein Sodium Injection

Study type: Interventional

Funder types: Other

Identifiers

NCT03823144

18-010370

NCI-2021-02676 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 85 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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85 participants in 1 patient group

Arm 1

Experimental group

Description:

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

Treatment:

Drug: Fluorescein Sodium Injection

Device: Diagnostic Microscopy