Status:
RECRUITING
Intravital Microscopy in Human Solid Tumors
Lead Sponsor:
Mayo Clinic
Conditions:
Solid Tumor, Adult
Clinical Stage IV Gastric Cancer AJCC v8
Eligibility:
All Genders
18+ years
Phase:
NA
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-t...
Detailed Description
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 O...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 28 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2026
Estimated Enrollment :
85 Patients enrolled
Trial Details
Trial ID
NCT03823144
Start Date
February 28 2019
End Date
September 30 2026
Last Update
December 11 2025
Active Locations (1)
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1
Mayo Clinic Florida
Jacksonville, Florida, United States, 32224