A Study of Intravital Microscopy (IVM) in Human Solid Tumors

Overview

About this study

The purpose of this study is to determine the feasibility of performing HIVM in patients with deep space solid tumors during standard course of surgical resection.

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:

  • Age ≥ 18 years of age.
  • ECOG Performance Status of ≤ 2.
  • Measurable tumor by direct visualization requiring surgical resection in the OR.
  • Tumor types of origin include gastric, pancreatic, hepatobiliary, colorectal, and sarcoma. Tumors may be primary or metastatic to solid or hollow intra-abdominal organs.
  • Subject must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent..
  • Subject must have a skin prick test pre-operatively (at the time of the preoperative visit and after signed informed consent for entry into this clinical trial is given) to determine any sensitivity 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 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, including T wave inversion, elevated T waves, prolonged QRS interval, or conduction blocks) or that requires further work-up (including cardiac echo or stress test).
  • Any condition that excludes surgery as the standard of care (e.g. high disease burden where alternative treatments like systemic chemotherapy would be preferred).

 

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 Contact

Jacksonville, Fla.

Mayo Clinic principal investigator

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

Open for enrollment

Contact information:

Natalie Fares

(904)953-3880

Fares.Natalie@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20453746

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