Real-time imaging of tumor blood vessels during surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This trial uses human intravital microscopy (HIVM) to visualize tumor-associated blood vessels in real time during standard surgical resections. Participants receive an intravenous dose of fluorescein and surgeons record 1–2 minutes of intravital imaging per field over the tumor and nearby normal tissue. Investigators will compare vessel function between tumor and adjacent normal tissue, correlate imaging features with tumor grade on pathology, and follow patients to explore links between microvascular features and survival. The primary aim is to determine the feasibility and safety of performing HIVM in patients with deep-space solid tumors during routine operations.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age ≥ 18 years of age
* Eastern Cooperative Oncology Group (ECOG)Performance Status of ≤ 2
* Measurable tumor by direct visualization requiring surgical resection in the operating room (OR)
* Tumor types of origin include gastric, pancreatic, hepatobiliary, colorectal, sarcoma, brain, or breast cancer that may involve the axillary lymph nodes cancers. Tumors may be primary or metastatic
* 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 glomerular filtration rate (GFR) \< 45
* Liver dysfunction as defined by Child-Pugh score \> 5, or liver function test (LFT)'s 1.5 x 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 electrocardiography \[EKG\], 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 surgical resection as the standard of care for the patient

Where it's running

• Mayo Clinic Florida
  Jacksonville, Florida, United States Recruiting

Study contacts

• Principal investigator: Emmanuel M Gabriel, M.D., Ph.D. — Mayo Clinic
• Study coordinator: Emmanuel M Gabriel, M.D., Ph.D.
• Email: gabriel.emmanuel@mayo.edu
• Phone: 904-953-2523

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.