Clinical trial NCT03517852: Intravital Microscopy (IVM) in Patients With Peritoneal Carcinomatosis (PC)
Official title: Intravital Microscopy (IVM) in Patients With Peritoneal Carcinomatosis (PC)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peritoneal Carcinomatosis
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2018-05-08
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This study will investigate the tumor-associated vasculature of patients with peritoneal carcinomatosis, or cancer that spreads along the inner abdominal lining. The investigators will use a technology known as intravital microscopy (IVM) in order to visualize in real-time the tumor-associated vessels of peritoneal disease. 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Tumor vessel identification (# tumor vessels visualized per high power field)
timeFrame: 15-20 minutes
measure: Tumor vessel density (# tumor vessels per square cm area observed)
timeFrame: 15-20 minutes
measure: Fluorescent dye uptake (# tumor vessels with fluorescent dye uptake and # tumor vessels without dye uptake)
timeFrame: 15-20 minutes
measure: Tumor blood flow (velocity, mm/sec)
timeFrame: 15-20 minutes
Secondary outcomes:
measure: Post-operative comparison of the microvasculature of peritoneal carcinomatosis with normal tissue (peritoneum)
timeFrame: 15-20 minutes
measure: 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).
timeFrame: 5-7 days
measure: Post-operative correlation of the microscopic observation of the tumor microvasculature tumor-specific and overall survival.
timeFrame: 5 years
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic Florida
state: Florida
Study officials:
affiliation: Mayo Clinic
name: Emmanuel M Gabriel, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
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