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NCT Number: NCT03517852

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

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.

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Key information

Conditions

Peritoneal Carcinomatosis Abdominal Neoplasms Digestive System Diseases Digestive System Neoplasms Neoplasms Neoplasms by Site Peritoneal Diseases Peritoneal Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic Florida

Jacksonville, Florida, 32224, United States

About this study

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):

  • Compare the microscopic observation of the tumor-associated vessels with normal tissue (peritoneal surface) in each individual subject.
  • Correlate the microscopic observations of the tumor-associated vessels with pathologic grade of tumor implants.
  • Correlate the microscopic observation of the microvasculature with tumor-specific and overall survival.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 18 years of age.
  • Have an ECOG Performance Status of ≤ 2. Refer to Appendix C.
  • Have measurable disease in the peritoneum by direct visualization (visible lesion typically > 0.5 cm in maximal diameter).
  • Carcinomatosis that meets indications for CRS-HIPEC.
  • 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.
  • A negative skin-prick test to fluorescein.

Exclusion criteria

  • 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 GFR < 45.
  • Liver dysfunction as defined by Child-Pugh score > 5, or LFT's 1.5x above normal range.
  • Any known allergy or prior reaction to fluorescein or ICG or a positive skin prick test to fluorescein.
  • Pregnant or nursing female subjects, determined preoperatively with a urine pregnancy test.
  • Unwilling or unable to follow protocol requirements.
  • Any condition which in the Investigators' opinion deems the patient unsuitable (e.g., abnormal EKG).
  • Any condition that excludes CRS-HIPEC as the standard of care for the patient.

Treatment and study plan

Human Intravital Microscopy

Device

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

Primary outcomes

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

    Time frame: 15-20 minutes

    Identify and measure vessels associated with peritoneal tumor implants

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

    Time frame: 15-20 minutes

    Determine vessel density per 10x field

  3. 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)]

  4. 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.

Secondary outcomes

  1. 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).

  2. 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).

  3. 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.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2023
First posted
May 8, 2018
Registry last updated
Jan 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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