Intravital Microscopy in Human Solid Tumors

This study is looking at how blood vessels in solid tumors work. Researchers will use a special camera called intravital microscopy (IVM) to see these tiny blood vessels in real-time during surgery. You would also receive an injection of Fluorescein Sodium, a dye that helps visualize the vessels. The goal is to see if the way these vessels function could help doctors decide if certain treatments would work well for you. This study is for adults with solid tumors, including gastric, colorectal, pancreatic, and other types, who are having surgery to remove their tumor. Success in this study means being able to clearly see and count the tumor vessels and how they take up the dye. The current status of this study is unclear, and it plans to enroll 85 participants.

Study design: This is an interventional study that plans to enroll 85 participants. It is not specified if it is randomized or blinded.
What's involved: You would receive an intravenous injection of Fluorescein Sodium and undergo intravital microscopy for 1-2 minutes per field during your surgery.
Compensation: Not stated in the trial record.
Follow-up: You will be followed up 2-3 weeks after surgery.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

Intravital Microscopy in Human Solid Tumors

Recruiting

NAAges 18+InterventionalDiagnostic

Mayo Clinic

~85 participants

Updated 2026-06-02 on ClinicalTrials.gov

What's tested:Diagnostic MicroscopyFluorescein Sodium Injection

At a glance

Recruiting sites

1 of 1 listed site is recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

1. Tumor vessel identification (# tumor vessels visualized per high power field)

Measured over 12-15 minutes

+3 more outcomes measured

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

NCT03823144

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

Mayo Clinic Florida
Jacksonville, Floridastudy coordinator listed
Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

Emmanuel M Gabriel, M.D., Ph.D. · PRINCIPAL_INVESTIGATOR · Mayo Clinic

Who to contact

Emmanuel M Gabriel, M.D., Ph.D.

[email protected]

904-953-2523

Email the study team

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Eligibility criteria

Inclusion

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

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

What this trial measures

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.

Trialytics