Find trials
Search tips

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

Overview

About this study

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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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 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.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status

Jacksonville, Fla.

Mayo Clinic principal investigator

Emmanuel Gabriel, M.D., Ph.D.

Closed for enrollment

More information

Publications

Publications are currently not available

More about research at Mayo Clinic

.
CLS-20425088

Mayo Clinic Footer