Intravital Microscopy (IVM) in Patients With Peritoneal Carcinomatosis (PC)

Primary objective(s): To determine the feasibility and clinical utility of performing HIVM in
patients with peritoneal carcinomatosis during standard course of treatment (cytoreductive
surgery with hyperthermic intraperitoneal chemotherapy, or CRS-HIPEC).

Secondary objective(s):

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

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

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

Inclusion Criteria:

1. Age ≥ 18 years of age.

2. Have an ECOG Performance Status of ≤ 2. Refer to Appendix C.

3. Have measurable disease in the peritoneum by direct visualization (visible lesion
typically > 0.5 cm in maximal diameter).

4. Carcinomatosis that meets indications for CRS-HIPEC.

5. Subject must understand the investigational nature of this study and sign an
Independent Ethics Committee/Institutional Review Board approved written informed
consent form prior to receiving any study related procedure.

6. A negative skin-prick test 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 ICG 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).

8. Any condition that excludes CRS-HIPEC as the standard of care for the patient.