Intravital microscopy in patients with peritoneal carcinomatosis

Mayo Clinic0 个研究点目标入组 30 人开始时间: 2020年11月25日最近更新: 2023年12月19日

适应症

试验速览

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

•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

•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

发起方