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Intravital Microscopy in Human Solid Tumors

ConditionsSolid Tumor, AdultClinical Stage IV Gastric Cancer AJCC v8Malignant Solid NeoplasmMetastatic Colorectal CarcinomaMetastatic Gastric CarcinomaMetastatic Primary Malignant Brain NeoplasmMetastatic SarcomaPostneoadjuvant Therapy Stage IV Gastric Cancer AJCC v8Resectable Colorectal CarcinomaResectable Liver and Intrahepatic Bile Duct CarcinomaResectable Pancreatic CarcinomaResectable SarcomaStage IV Colorectal Cancer AJCC v8Anatomic Stage IV Breast Cancer AJCC v8Malignant Brain NeoplasmMetastatic Breast CarcinomaMetastatic Liver CarcinomaMetastatic Pancreatic CarcinomaResectable Brain NeoplasmResectable Breast CarcinomaResectable Gastric CarcinomaStage IV Hepatocellular Carcinoma AJCC v8Stage IV Pancreatic Cancer AJCC v8
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMayo Clinic

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Diagnostic Microscopy

    Device

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

  • Fluorescein Sodium Injection

    Drug

    Given IV as part of IVM procedure

Treatment groups

85 Participants
are divided into 1 treatment group
Group A: Arm 1Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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

Identify and measure vessels associated with solid tumors

Time frame
12-15 minutes
2

2. Tumor vessel density (# tumor vessels per square cm area observed)

Determine vessel density per 10x field

Time frame
12-15 minutes
3

3. Fluorescent dye uptake (# tumor vessels with fluorescent dye uptake and # tumor vessels without dye uptake)

Visualize vital dye within the vessels (fluorescein)

Time frame
12-15 minutes
4

4. Tumor blood flow (velocity, mm/sec)

Calculate the blood flow velocity of the vessels and tissue penetration of fluorescent dye as a marker of vessel permeability.

Time frame
12-15 minutes

Secondary outcomes

1

5. Post-operative comparison of the microvasculature of tumor with normal tissue

Post-operative comparison of the microvasculature of tumor with normal tissue (e.g. peritoneum) in each individual subject using vessel diameters, vessel density, detection of intravital dye and flow rates.

Time frame
15-20 minutes
2

6. Post-operative correlation of the microvasculature with pathologic features of the tumor implants (i.e. tumor grade) at the time of the final pathology report (5-7 days after surgery).

The investigators will determine if there is a correlation between the microvasculature with pathologic features of the tumor implants (i.e. tumor grade) at the time of the final pathology report (5-7 days after surgery).

Time frame
5-7 days
3

Post-operative correlation of the microscopic observation of the tumor microvasculature tumor-specific and overall survival.

The investigators will determine if there is a correlation between the microscopic observation of the tumor microvasculature tumor-specific and overall survival.

Time frame
5 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mayo Clinic

Lead sponsor

Source ClinicalTrials.gov
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