Intravital Microscopy in Human Solid Tumors
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|ClinicalTrials.gov Identifier: NCT03823144|
Recruitment Status : Not yet recruiting
First Posted : January 30, 2019
Last Update Posted : February 20, 2019
|Condition or disease||Intervention/treatment||Phase|
|Solid Tumor, Adult||Device: Human Intravital Microscopy||Not Applicable|
Primary objective(s): To determine the feasibility and clinical utility of performing HIVM in patients with solid tumors during standard course of treatment (surgical resection).
- Compare the microscopic observation of the tumor-associated vessels with normal tissue (e.g. peritoneal surface) in each individual subject.
- Correlate the microscopic observations of the tumor-associated vessels with pathologic grade of tumor.
- To correlate the microscopic observation of the microvasculature with tumor-specific and overall survival.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Masking Description:||This is an open-label, non-randomized, single center, study of IVM observation in conjunction with fluorescein in subjects with solid tumors undergoing surgical resection.|
|Official Title:||Intravital Microscopy (IVM) in Human Solid Tumors|
|Estimated Study Start Date :||February 28, 2019|
|Estimated Primary Completion Date :||December 31, 2019|
|Estimated Study Completion Date :||December 31, 2019|
Experimental: Arm 1
Determine the feasibility and clinical utility of performing Human Intravital Microscopy (HIVM) in patients with solid tumors during surgical resection.
Device: Human Intravital Microscopy
Intravital microscopy (IVM) allows real-time, direct visualization of microscopic blood vessels and calculation of blood flow.
- 1. Tumor vessel identification (# tumor vessels visualized per high power field) [ Time Frame: 12-15 minutes ]Identify and measure vessels associated with solid tumors
- 2. Tumor vessel density (# tumor vessels per square cm area observed) [ Time Frame: 12-15 minutes ]Determine vessel density per 10x field
- 3. Fluorescent dye uptake (# tumor vessels with fluorescent dye uptake and # tumor vessels without dye uptake) [ Time Frame: 12-15 minutes ]Visualize vital dye within the vessels (fluorescein)
- 4. Tumor blood flow (velocity, mm/sec) [ Time Frame: 12-15 minutes ]Calculate the blood flow velocity of the vessels and tissue penetration of fluorescent dye as a marker of vessel permeability.
- 5. Post-operative comparison of the microvasculature of tumor with normal tissue [ Time Frame: 15-20 minutes ]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.
- 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). [ Time Frame: 5-7 days ]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).
- Post-operative correlation of the microscopic observation of the tumor microvasculature tumor-specific and overall survival. [ Time Frame: 5 years ]The investigators will determine if there is a correlation between the microscopic observation of the tumor microvasculature tumor-specific and overall survival.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03823144
|Contact: Emmanuel M Gabriel, M.D., Ph.D.||email@example.com|
|Contact: Michael B Wallace, M.D.||firstname.lastname@example.org|
|United States, Florida|
|Mayo Clinic Florida||Not yet recruiting|
|Jacksonville, Florida, United States, 32224|
|Contact: Emmanuel M Gabriel, M.D., Ph. D. 904-953-2523 email@example.com|
|Principal Investigator: Emmanuel M Gabriel, M.D., Ph. D.|
|Sub-Investigator: Michael B Wallace, M.D.|
|Principal Investigator:||Emmanuel M Gabriel, M.D., Ph.D.||Mayo Clinic|