Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID03823144

Intravital Microscopy (IVM) in Human Solid Tumors

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

85

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

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

Trial Site Locations

Total: 1 location

1

Mayo Clinic Florida

Jacksonville, Florida, United States, 32224

Actively Recruiting

Loading map...

Research Team

E

Emmanuel M Gabriel, M.D., Ph.D.

M

Michael B Wallace, M.D.

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

Similar Trials

A Phase II Pilot Study of Lutetium (177Lu)-DOTATATE Treatmen...

Anatomic Stage IV Breast Cancer AJCC v8

Actively Recruiting

1 location

A First-in-Human, Phase I/II PET Imaging Study of 64Cu-GRIP ...

Prostate Cancer

Actively Recruiting

1 location

A Phase 1/2a Study Utilizing 64Cu-LNTH-1363S (64Cu Radiolabe...

Metastatic Sarcoma

Actively Recruiting

5 locations

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

Published Research Related To This Trial