Intravital Microscopy in Human Solid Tumors

Launched by MAYO CLINIC · Jan 28, 2019

Keywords

ClinConnect Summary

This clinical trial is studying how blood vessels in solid tumors—such as those found in cancers of the stomach, pancreas, liver, colon, breast, brain, and soft tissues—work in real-time during surgery. Using a special imaging technique called intravital microscopy, doctors will look directly at the tumor’s blood vessels to see if they are healthy enough to allow cancer medications to reach the tumor effectively. This could help personalize treatment plans based on how well the tumor’s vessels can deliver medicine.

Adults 18 years and older who have solid tumors that need to be surgically removed may be eligible to join, provided they are generally well enough for surgery and able to understand the study. Before surgery, participants will have a simple skin test to check for allergies to a dye used in the imaging. During the operation, doctors will use the imaging technique to observe the tumor’s blood vessels. This study does not change the standard treatment but adds this imaging to better understand each patient’s tumor. People with certain health problems, allergies to the dye, or who are pregnant will not be able to join. Overall, this study aims to help improve how cancer treatments are delivered by learning more about tumor blood flow.

Gender

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Eligibility 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