Intravital Microscopy in Human Solid Tumors
Recruiting now · Not applicable
Conditions 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
In brief
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 facts
- Study ID
- NCT03823144
- Run by
- Mayo Clinic
- People needed
- 85
- Starts
- 2019-02-28
- Expected to finish
- 2027-09-30
- Last updated by the study team
- 2026-06-02
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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 is running
- Mayo Clinic Florida — Jacksonville, Florida, United States (enrolling)
Full record on ClinicalTrials.gov
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