sing microscopes to observe tumor vessels

Not Applicable

• Conditions: Peritoneal carcinomatosis; Cancer

• Registration Number: ISRCTN10645335
• Lead Sponsor: Mayo Clinic

Brief Summary

2021 Results article in https://pubmed.ncbi.nlm.nih.gov/33654117/ (added 06/01/2022)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-11-25
• Last Update Posted: 19 December 2023
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. Age =18 years of age
2. Have an ECOG Performance Status of =2
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 the 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 & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Identify and measure number of vessels associated with peritoneal tumor implants using intravital microscopy at the time of surgery (vessels visualized per high power field)<br>2. Tumor vessel density (tumor vessels per square cm area observed) as above<br>3. Number of tumor vessels with fluorescent dye uptake and number of tumor vessels without dye uptake)<br>4.Tumor blood flow (velocity, mm/sec) of the vessels and tissue penetration of fluorescent dyes as markers of vessel permeability using intravital microscopy at the time of surgery

Secondary Outcome Measures

Name	Time	Method
1. Diameters, vessel density, detection of intravital dye and flow rates of the microvasculature of peritoneal carcinomatosis compared with normal tissue using intravital microscopy at the time of surgery<br>2. Pathologic features of the tumor implants (i.e. tumor grade) measured by the investigators at the time of the final pathology report (5-7 days after surgery)<br>3. Overall survival at 1 and 2 years