What is this study trying to find out about solid tumors?

This study aims to see if a new imaging technique called human intravital microscopy (HIVM) can be used during surgery to look at the blood vessels in solid tumors. Researchers want to understand how these blood vessels differ from normal tissue and how these differences relate to tumor grade and survival. The Mayo Clinic is leading this research to better understand tumor blood flow.

Who may be eligible for this solid tumor clinical trial?

Adults 18 years or older with solid tumors requiring surgical removal may be eligible. Participants should have a good performance status and no allergies to fluorescein dye. Both men and women can participate. Please review eligibility criteria for more details.

Is there any cost to participate in this solid tumor clinical trial?

Study-related care, including the use of the study imaging procedure and all trial visits, is provided at no cost. Personal travel and other expenses may vary and are generally not covered by the study.

Actively Recruiting

Phase Not Applicable

Age: 18Years +

All Genders

ID03823144

Using Intravital Microscopy to Study Blood Vessels in Solid Tumors During Surgery

Led by Mayo Clinic · Updated on 2026-06-02

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are exploring the blood vessels associated with solid tumors in adult patients using a method called human intravital microscopy HIVM. This study aims to see if HIVM can be done safely during surgery to remove tumors and to learn how tumor blood vessels differ from normal tissue. The study will also examine if these vessel characteristics relate to tumor grade and patient survival. Participants receive an intravenous injection of fluorescein dye during surgery, and HIVM is performed for 1-2 minutes to view the tumor vessels in real time. The study focuses on tumors from various cancers including gastric, pancreatic, liver, colorectal, sarcoma, brain, and breast cancers. After surgery, patients are followed up 2-3 weeks later. During the study, researchers will measure tumor vessel number, density, dye uptake, and blood flow using HIVM. They will compare tumor vessels to normal tissue vessels and correlate these findings with tumor pathology and survival over up to five years. The total involvement includes surgery, HIVM imaging, and post-operative follow-up assessments.

CONDITIONS

Brief Title

Intravital Microscopy in Human Solid Tumors

How This Trial Compares With Other Options

This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.

Factors	IVM Imaging During Surgery	Routine Histopathology (Current Practice)
What it is	Intravital microscopy (IVM) is a diagnostic imaging technique performed during surgery to visualize microscopic blood vessels in living tumor tissue. Fluorescein sodium is injected intravenously to highlight blood flow.	Routine histopathology is the laboratory examination of resected tumor tissue, using light microscopy and staining techniques to assess cancer type and features.
Role in trial	Serves as the main investigational diagnostic imaging performed during surgery among eligible patients.	Used as the clinical benchmark and reference standard for tumor diagnosis after surgical resection.
Primary use	Real-time identification and measurement of tumor microvasculature, vessel density, dye uptake, and blood flow during surgery to aid scientific understanding.	Diagnosis and staging of tumor type, grade, and other pathologic features using fixed tissue samples examined after surgery.
How it is given or performed	Conducted in the operating room during tumor resection. Fluorescein sodium is given intravenously. Microscopy images are captured of tumor vessels in real time.	Tumor tissue is removed during surgery, fixed, stained, and examined by pathologists using standard laboratory microscopes.
Evidence status	IVM is supported by pilot clinical studies and ongoing research for tumor vessel imaging. Evidence is preliminary and aims to enhance intraoperative vascular assessment.	Routine histopathology is a well-established clinical standard with extensive validation for cancer diagnosis, staging, and guiding treatment.
Important limitations	IVM is limited by intraoperative access, small observation area, and the need for intravenous contrast. Clinical utility and broader diagnostic impact remain under investigation.	Histopathology cannot provide real-time vessel visualization during surgery and is subject to potential sampling error or delay in diagnosis.

Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Age 18 years or older
ECOG Performance Status of 2 or less
Measurable tumor requiring surgical removal in the operating room
Tumor types include gastric, pancreatic, hepatobiliary, colorectal, sarcoma, brain, or breast cancer, primary or metastatic
Ability to understand and sign informed consent
Negative skin prick test for fluorescein sensitivity before surgery

You will not qualify if you...

Uncontrolled illness such as active infection, heart failure, unstable angina, arrhythmia, or psychiatric/social issues
Kidney dysfunction with GFR less than 45
Liver dysfunction with Child-Pugh score above 5 or liver tests 1.5 times above normal
Known allergy or prior reaction to fluorescein or positive skin test
Pregnant or nursing women
Unable or unwilling to follow study procedures
Conditions making patient unsuitable or needing further cardiac evaluation
Conditions excluding surgical tumor removal as standard care

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person) for eligibility screening including a skin prick test for fluorescein sensitivity

Diagnostic Evaluation

Duration - Surgical day

Participants receive fluorescein intravenously and undergo Human Intravital Microscopy (HIVM) during surgical tumor resection, allowing real-time visualization of tumor-associated blood vessels for approximately 12-15 minutes.

1 visit coinciding with the surgical tumor removal

Post-operative Follow-up

Duration - 2 to 3 weeks after surgery

Participants are followed up to compare microvasculature observations with normal tissue and correlate findings with tumor pathology and survival.

1 follow-up visit approximately 2 to 3 weeks after surgery