Intravital Microscopy in Human Solid Tumors

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03823144
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Mayo Clinic
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Emmanuel M Gabriel, M.D., Ph.D.
Principal Investigator Affiliation Mayo Clinic
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Solid Tumor, Adult, Clinical Stage IV Gastric Cancer AJCC v8, Malignant Solid Neoplasm, Metastatic Colorectal Carcinoma, Metastatic Gastric Carcinoma, Metastatic Primary Malignant Brain Neoplasm, Metastatic Sarcoma, Postneoadjuvant Therapy Stage IV Gastric Cancer AJCC v8, Resectable Colorectal Carcinoma, Resectable Liver and Intrahepatic Bile Duct Carcinoma, Resectable Pancreatic Carcinoma, Resectable Sarcoma, Stage IV Colorectal Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8, Malignant Brain Neoplasm, Metastatic Breast Carcinoma, Metastatic Liver Carcinoma, Metastatic Pancreatic Carcinoma, Resectable Brain Neoplasm, Resectable Breast Carcinoma, Resectable Gastric Carcinoma, Stage IV Hepatocellular Carcinoma AJCC v8, Stage IV Pancreatic Cancer AJCC v8
Study Website: View Trial Website
Additional Details

PRIMARY OBJECTIVE:

  • I. To determine the feasibility of performing human intravital microscopy (HIVM) in patients with deep space solid tumors during standard course of surgical resection.
SECONDARY OBJECTIVES:
  • I. Compare the microscopic observation of the tumor-associated vessels with normal tissue (e.g. peritoneal surface or normal brain tissue) in each individual subject.
  • II. Correlate the microscopic observations of the tumor-associated vessels with pathologic grade of tumor.
  • III. To correlate the microscopic observation of the microvasculature with tumor-specific and overall survival.
OUTLINE: Patients receive fluorescein intravenously (IV) and undergo HIVM over 1-2 minutes per field. After completion of study, patients are followed up at 2-3 weeks after surgery.

Arms & Interventions

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

Device: - Diagnostic Microscopy

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

Drug: - Fluorescein Sodium Injection

Given IV as part of IVM procedure

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Mayo Clinic Florida, Jacksonville, Florida

Status

Recruiting

Address

Mayo Clinic Florida

Jacksonville, Florida, 32224

Site Contact

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

[email protected]

904-953-2523

Stay Informed & Connected