RecruitingNot ApplicableNCT03823144

Intravital Microscopy in Human Solid Tumors

Intravital Microscopy (IVM) in Human Solid Tumors

Sponsor

Mayo Clinic

Enrollment

85 participants

Start Date

Feb 28, 2019

Study Type

INTERVENTIONAL

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria6

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 Criteria8

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

Interventions

DEVICEDiagnostic Microscopy

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

DRUGFluorescein Sodium Injection

Given IV as part of IVM procedure

Locations(1)

Mayo Clinic Florida

Jacksonville, Florida, United States

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NCT03823144

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