Recruiting

Intravital Microscopy

Sponsor:

Mayo Clinic

Code:

NCT03823144

Conditions

Solid Tumor, Adult

Clinical Stage IV Gastric Cancer AJCC v8

Malignant Solid Neoplasm

Metastatic Colorectal Carcinoma

Metastatic Gastric Carcinoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Diagnostic Microscopy

Fluorescein Sodium Injection

Study Details

Brief summary:

This study will investigate the tumor-associated vasculature of patients with solid tumors. The investigators will use a technology known as intravital microscopy (IVM) in order to visualize in real-time the vessels associated with solid tumors. 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.

Conditions

Solid Tumor, Adult

Clinical Stage IV Gastric Cancer AJCC v8

Malignant Solid Neoplasm

Metastatic Colorectal Carcinoma

Metastatic Gastric Carcinoma

Study ID

NCT03823144

Start date

Feb 28, 2019

Status verified date

May, 2026

Completion date

Sep 30, 2027

Anticipated

Primary completion date

Sep 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

85 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Arm 1

Determine the feasibility and clinical utility of performing Human Intravital Microscopy (HIVM) in patients with solid tumors during surgical resection.

Interventions

Diagnostic Microscopy

Undergo Intravital microscopy (IVM), which allows real-time, direct visualization of microscopic blood vessels and calculation of blood flow.

Fluorescein Sodium Injection

Given IV as part of IVM procedure

Primary outcome measure

  • 1. Tumor vessel identification (# tumor vessels visualized per high power field) [ Time Frame: 12-15 minutes ]
  • 2. Tumor vessel density (# tumor vessels per square cm area observed) [ Time Frame: 12-15 minutes ]
  • 3. Fluorescent dye uptake (# tumor vessels with fluorescent dye uptake and # tumor vessels without dye uptake) [ Time Frame: 12-15 minutes ]
  • 4. Tumor blood flow (velocity, mm/sec) [ Time Frame: 12-15 minutes ]

Central Contacts and Locations

Central contacts

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

904-953-2523gabriel.emmanuel@mayo.edu

Michael B Wallace, M.D.

904-953-2221wallace.michael@mayo.edu

Locations

Mayo Clinic Florida

Recruiting

Jacksonville, Florida, United States, 32224

Contacts

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

904-953-2523gabriel.emmanuel@mayo.edu

Principal Investigator:

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

More Information

Sponsor

Mayo Clinic

Last update posted

Jun 2, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-06-02.