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

Sponsor
Mayo Clinic (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT03517852
Collaborator
(none)
30
Enrollment
1
Location
1
Arm
71.3
Anticipated Duration (Months)
0.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Human Intravital Microscopy
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Masking Description:
This is an open-label, non-randomized, single center, study of IVM observation in conjunction with fluorescein and ICG in subjects with peritoneal carcinomatosis undergoing CRS-HIPEC.
Primary Purpose:
Diagnostic
Official Title:
Intravital Microscopy (IVM) in Patients With Peritoneal Carcinomatosis (PC)
Actual Study Start Date :
Aug 15, 2018
Actual Primary Completion Date :
Jul 23, 2019
Anticipated Study Completion Date :
Jul 23, 2024

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Tumor vessel identification (# tumor vessels visualized per high power field) [15-20 minutes]

    Identify and measure vessels associated with peritoneal tumor implants

  2. Tumor vessel density (# tumor vessels per square cm area observed) [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) [15-20 minutes]

    Visualize vital dyes within the vessels [fluorescein and indocyanine green (ICG)]

  4. Tumor blood flow (velocity, mm/sec) [15-20 minutes]

    Calculate the blood flow velocity of the vessels and tissue penetration of fluorescent dyes as markers of vessel permeability.

Secondary Outcome Measures

  1. Post-operative comparison of the microvasculature of peritoneal carcinomatosis with normal tissue (peritoneum) [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). [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. [5 years]

    The investigators will determine if there is a correlation between the microscopic observation of the tumor microvasculature tumor-specific and overall survival.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Mayo Clinic Florida Jacksonville Florida United States 32224

Sponsors and Collaborators

  • Mayo Clinic

Investigators

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

Study Documents (Full-Text)

More Information

Additional Information:

Publications

Responsible Party:
Emmanuel M. Gabriel, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT03517852
Other Study ID Numbers:
  • 17-009823
First Posted:
May 8, 2018
Last Update Posted:
Feb 15, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Additional relevant MeSH terms:
Carcinoma
Peritoneal Neoplasms

Study Results

No Results Posted as of Feb 15, 2022