2019-02-28
2024-05-30
2024-05-30
51
NCT03823144
Mayo Clinic
Mayo Clinic
INTERVENTIONAL
Intravital Microscopy in Human Solid Tumors
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.
PRIMARY OBJECTIVE: To determine the feasibility and clinical utility of performing HIVM in patients with solid tumors during standard course of treatment (surgical resection). SECONDARY OBJECTIVES: 1. Compare the microscopic observation of the tumor-associated vessels with normal tissue (e.g. peritoneal surface or normal brain tissue) in each individual subject. 2. Correlate the microscopic observations of the tumor-associated vessels with pathologic grade of tumor. 3. To correlate the microscopic observation of the microvasculature with tumor-specific and overall survival. OUTLINE: Patients receive fluorescein intravenously (IV) and undergo HIVM over 1-2 minutes per field. After completion of study, patients are followed up at 2-3 weeks after surgery.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2019-01-28 | N/A | 2025-01-07 |
2019-01-28 | N/A | 2025-01-09 |
2019-01-30 | N/A | 2025-01 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Diagnostic
Allocation:
Na
Interventional Model:
Single Group
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| EXPERIMENTAL: Arm 1 Determine the feasibility and clinical utility of performing Human Intravital Microscopy (HIVM) in patients with solid tumors during surgical resection. | DEVICE: Diagnostic Microscopy
DRUG: Fluorescein Sodium Injection
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| 1. Tumor vessel identification (# tumor vessels visualized per high power field) | Identify and measure vessels associated with solid tumors | 12-15 minutes |
| 2. Tumor vessel density (# tumor vessels per square cm area observed) | Determine vessel density per 10x field | 12-15 minutes |
| 3. Fluorescent dye uptake (# tumor vessels with fluorescent dye uptake and # tumor vessels without dye uptake) | Visualize vital dye within the vessels (fluorescein) | 12-15 minutes |
| 4. Tumor blood flow (velocity, mm/sec) | Calculate the blood flow velocity of the vessels and tissue penetration of fluorescent dye as a marker of vessel permeability. | 12-15 minutes |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| 5. Post-operative comparison of the microvasculature of tumor with normal tissue | Post-operative comparison of the microvasculature of tumor with normal tissue (e.g. peritoneum) in each individual subject using vessel diameters, vessel density, detection of intravital dye and flow rates. | 15-20 minutes |
| 6. Post-operative correlation of the microvasculature with pathologic features of the tumor implants (i.e. tumor grade) at the time of the final pathology report (5-7 days after surgery). | The investigators will determine if there is a correlation between the microvasculature with pathologic features of the tumor implants (i.e. tumor grade) at the time of the final pathology report (5-7 days after surgery). | 5-7 days |
| Post-operative correlation of the microscopic observation of the tumor microvasculature tumor-specific and overall survival. | The investigators will determine if there is a correlation between the microscopic observation of the tumor microvasculature tumor-specific and overall survival. | 5 years |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
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