Intravital Microscopy in Human Solid Tumors

Primary objective(s): To determine the feasibility and clinical utility of performing HIVM in
patients with solid tumors during standard course of treatment (surgical resection).

Secondary objective(s):

1. Compare the microscopic observation of the tumor-associated vessels with normal tissue
(e.g. peritoneal surface) in each individual subject.

2. Correlate the microscopic observations of the tumor-associated vessels with pathologic
grade of tumor.

3. To correlate the microscopic observation of the microvasculature with tumor-specific and
overall survival.

Inclusion Criteria:

1. Age ≥ 18 years of age.

2. ECOG Performance Status of ≤ 2.

3. Measurable tumor by direct visualization requiring surgical resection in the OR.

4. Tumor types of origin include gastric, pancreatic, hepatobiliary, colorectal, and
sarcoma. Tumors may be primary or metastatic to solid or hollow intra-abdominal
organs.

5. Subject must understand the investigational nature of this study and sign an
Independent Ethics Committee/Institutional Review Board approved written informed
consent.

6. 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:

1. 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.

2. Renal dysfunction as defined as a GFR < 45.

3. Liver dysfunction as defined by Child-Pugh score > 5, or LFT's 1.5x above normal
range.

4. Any known allergy or prior reaction to fluorescein or a positive skin prick test to
fluorescein.

5. Pregnant or nursing female subjects, determined preoperatively with a urine pregnancy
test.

6. Unwilling or unable to follow protocol requirements.

7. Any condition which in the Investigators' opinion deems the patient unsuitable (e.g.,
abnormal 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).

8. Any condition that excludes surgery as the standard of care (e.g. high disease burden
where alternative treatments like systemic chemotherapy would be preferred).