Intravital Microscopy in Human Solid Tumors

Part of paid clinical trials in Jacksonville, Florida.

Sponsor
Mayo Clinic
Study ID
NCT03823144
Status
Recruiting
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Conditions

  • Anatomic Stage IV Breast Cancer AJCC v8
  • Clinical Stage IV Gastric Cancer AJCC v8
  • Malignant Brain Neoplasm
  • Malignant Solid Neoplasm
  • Metastatic Breast Carcinoma
  • Metastatic Colorectal Carcinoma
  • Metastatic Gastric Carcinoma
  • Metastatic Liver Carcinoma
  • Metastatic Pancreatic Carcinoma
  • Metastatic Primary Malignant Brain Neoplasm
  • Metastatic Sarcoma
  • Postneoadjuvant Therapy Stage IV Gastric Cancer AJCC v8
  • Resectable Brain Neoplasm
  • Resectable Breast Carcinoma
  • Resectable Colorectal Carcinoma
  • Resectable Gastric Carcinoma
  • Resectable Liver and Intrahepatic Bile Duct Carcinoma
  • Resectable Pancreatic Carcinoma
  • Resectable Sarcoma
  • Solid Tumor, Adult
  • Stage IV Colorectal Cancer AJCC v8
  • Stage IV Hepatocellular Carcinoma AJCC v8
  • Stage IV Pancreatic Cancer AJCC v8

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Diagnostic Microscopy — DEVICE
    Undergo Intravital microscopy (IVM), which allows real-time, direct visualization of microscopic blood vessels and calculation of blood flow.
  • Fluorescein Sodium Injection — DRUG
    Given IV as part of IVM procedure

Study Details

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.

Key Dates

Start date
Feb 28, 2019
Status verified
May 2026
Primary completion
Sep 30, 2027
Completion
Sep 30, 2027

Study Design

Enrollment
85 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Arm 1
    Determine the feasibility and clinical utility of performing Human Intravital Microscopy (HIVM) in patients with solid tumors during surgical resection.

Primary Outcome Measure

1. Tumor vessel identification (# tumor vessels visualized per high power field) [ Time Frame: 12-15 minutes ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Mayo Clinic FloridaJacksonvilleFlorida32224
Emmanuel M Gabriel, M.D., Ph. D.
[email protected]
904-953-2523
Emmanuel M Gabriel, M.D., Ph. D. (PRINCIPAL_INVESTIGATOR)
Michael B Wallace, M.D. (SUB_INVESTIGATOR)

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