Back to resultsIntravital Microscopy (IVM) in Patients With Peritoneal Carcinomatosis (PC)
Primary Purpose
Peritoneal Carcinomatosis
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Human Intravital Microscopy
Sponsored by
About this trial
This is an interventional diagnostic trial for Peritoneal Carcinomatosis
Eligibility Criteria
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.
Sites / Locations
- Mayo Clinic Florida
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Arm 1
Arm Description
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).
Outcomes
Primary Outcome Measures
Tumor vessel identification (# tumor vessels visualized per high power field)
Identify and measure vessels associated with peritoneal tumor implants
Tumor vessel density (# tumor vessels per square cm area observed)
Determine vessel density per 10x field
Fluorescent dye uptake (# tumor vessels with fluorescent dye uptake and # tumor vessels without dye uptake)
Visualize vital dyes within the vessels [fluorescein and indocyanine green (ICG)]
Tumor blood flow (velocity, mm/sec)
Calculate the blood flow velocity of the vessels and tissue penetration of fluorescent dyes as markers of vessel permeability.
Secondary Outcome Measures
Post-operative comparison of the microvasculature of peritoneal carcinomatosis with normal tissue (peritoneum)
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).
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).
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).
Post-operative correlation of the microscopic observation of the tumor microvasculature tumor-specific and overall survival.
The investigators will determine if there is a correlation between the microscopic observation of the tumor microvasculature tumor-specific and overall survival.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03517852
Brief Title
Intravital Microscopy (IVM) in Patients With Peritoneal Carcinomatosis (PC)
Official Title
Intravital Microscopy (IVM) in Patients With Peritoneal Carcinomatosis (PC)
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 15, 2018 (Actual)
Primary Completion Date
July 23, 2019 (Actual)
Study Completion Date
July 23, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
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
Data Monitoring Committee
No
5. 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.
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):
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peritoneal Carcinomatosis
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study 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.
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm 1
Arm Type
Experimental
Arm Description
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).
Intervention Type
Device
Intervention Name(s)
Human Intravital Microscopy
Intervention Description
Intravital microscopy (IVM) allows real-time, direct visualization of microscopic blood vessels and calculation of blood flow.
Primary Outcome Measure Information:
Title
Tumor vessel identification (# tumor vessels visualized per high power field)
Description
Identify and measure vessels associated with peritoneal tumor implants
Time Frame
15-20 minutes
Title
Tumor vessel density (# tumor vessels per square cm area observed)
Description
Determine vessel density per 10x field
Time Frame
15-20 minutes
Title
Fluorescent dye uptake (# tumor vessels with fluorescent dye uptake and # tumor vessels without dye uptake)
Description
Visualize vital dyes within the vessels [fluorescein and indocyanine green (ICG)]
Time Frame
15-20 minutes
Title
Tumor blood flow (velocity, mm/sec)
Description
Calculate the blood flow velocity of the vessels and tissue penetration of fluorescent dyes as markers of vessel permeability.
Time Frame
15-20 minutes
Secondary Outcome Measure Information:
Title
Post-operative comparison of the microvasculature of peritoneal carcinomatosis with normal tissue (peritoneum)
Description
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).
Time Frame
15-20 minutes
Title
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).
Description
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).
Time Frame
5-7 days
Title
Post-operative correlation of the microscopic observation of the tumor microvasculature tumor-specific and overall survival.
Description
The investigators will determine if there is a correlation between the microscopic observation of the tumor microvasculature tumor-specific and overall survival.
Time Frame
5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emmanuel M Gabriel, M.D., Ph.D.
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic Florida
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
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Intravital Microscopy (IVM) in Patients With Peritoneal Carcinomatosis (PC)
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