Recruiting

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.

ClinicalTrials.gov IDNCT03823144

PhaseNA

Enrollment85

SponsorMayo Clinic

Age18 Years

SexALL

I'm interested View official listing

Conditions studied

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

About this study

Interventions

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

Primary outcomes

1. Tumor vessel identification (# tumor vessels visualized per high power field) (12-15 minutes)
2. Tumor vessel density (# tumor vessels per square cm area observed) (12-15 minutes)
3. Fluorescent dye uptake (# tumor vessels with fluorescent dye uptake and # tumor vessels without dye uptake) (12-15 minutes)
4. Tumor blood flow (velocity, mm/sec) (12-15 minutes)

Eligibility information

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 locations

Mayo Clinic Florida, Jacksonville, Florida 32224 United States

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.