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

January 17, 2024 updated by: Emmanuel M. Gabriel, Mayo Clinic
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Jacksonville, Florida, United States, 32224
        • Mayo Clinic Florida

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 1
Determine the feasibility and clinical utility of performing Human Intravital Microscopy (HIVM) in patients with peritoneal carcinomatosis during standard course of treatment (cytoreductive surgery with hyperthermic intraperitoneal chemotherapy, or CRS-HIPEC).
Device: Human Intravital Microscopy
Intravital microscopy (IVM) allows real-time, direct visualization of microscopic blood vessels and calculation of blood flow.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tumor vessel identification (# tumor vessels visualized per high power field)
Time Frame: 15-20 minutes
Identify and measure vessels associated with peritoneal tumor implants
15-20 minutes
Tumor vessel density (# tumor vessels per square cm area observed)
Time Frame: 15-20 minutes
Determine vessel density per 10x field
15-20 minutes
Fluorescent dye uptake (# tumor vessels with fluorescent dye uptake and # tumor vessels without dye uptake)
Time Frame: 15-20 minutes
Visualize vital dyes within the vessels [fluorescein and indocyanine green (ICG)]
15-20 minutes
Tumor blood flow (velocity, mm/sec)
Time Frame: 15-20 minutes
Calculate the blood flow velocity of the vessels and tissue penetration of fluorescent dyes as markers of vessel permeability.
15-20 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-operative comparison of the microvasculature of peritoneal carcinomatosis with normal tissue (peritoneum)
Time Frame: 15-20 minutes
The investigators will compare the microvasculature of peritoneal carcinomatosis with normal tissue (peritoneum) in each individual subject using vessel characteristics (diameters, vessel density, detection of intravital dye and flow rates).
15-20 minutes
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).
Time Frame: 5-7 days
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).
5-7 days
Post-operative correlation of the microscopic observation of the tumor microvasculature tumor-specific and overall survival.
Time Frame: 5 years
The investigators will determine if there is a correlation between the microscopic observation of the tumor microvasculature tumor-specific and overall survival.
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Emmanuel M Gabriel, M.D., Ph.D., Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 15, 2018

Primary Completion (Actual)

July 23, 2019

Study Completion (Actual)

December 31, 2023

Study Registration Dates

First Submitted

April 13, 2018

First Submitted That Met QC Criteria

April 24, 2018

First Posted (Actual)

May 8, 2018

Study Record Updates

Last Update Posted (Estimated)

January 19, 2024

Last Update Submitted That Met QC Criteria

January 17, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17-009823

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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