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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
Sponsor:
Information provided by (Responsible Party):
Emmanuel M. Gabriel, Mayo Clinic

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Solid Tumor, Adult Device: Human Intravital Microscopy Not Applicable

Detailed Description:

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).

Secondary objective(s):

  1. Compare the microscopic observation of the tumor-associated vessels with normal tissue (e.g. peritoneal surface) 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.

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.
Primary Purpose: Diagnostic
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

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: Human Intravital Microscopy
Intravital microscopy (IVM) allows real-time, direct visualization of microscopic blood vessels and calculation of blood flow.




Primary Outcome Measures :
  1. 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. 2. Tumor vessel density (# tumor vessels per square cm area observed) [ Time Frame: 12-15 minutes ]
    Determine vessel density per 10x field

  3. 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. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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).

  3. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age ≥ 18 years of age.
  2. ECOG Performance Status of ≤ 2.
  3. Measurable tumor by direct visualization requiring surgical resection in the OR.
  4. Tumor types of origin include gastric, pancreatic, hepatobiliary, colorectal, and sarcoma. Tumors may be primary or metastatic to solid or hollow intra-abdominal organs.
  5. Subject must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent.
  6. 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:

  1. 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.
  2. Renal dysfunction as defined as a GFR < 45.
  3. Liver dysfunction as defined by Child-Pugh score > 5, or LFT's 1.5x above normal range.
  4. Any known allergy or prior reaction to fluorescein or a positive skin prick test to fluorescein.
  5. Pregnant or nursing female subjects, determined preoperatively with a urine pregnancy test.
  6. Unwilling or unable to follow protocol requirements.
  7. Any condition which in the Investigators' opinion deems the patient unsuitable (e.g., abnormal 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).
  8. Any condition that excludes surgery as the standard of care (e.g. high disease burden where alternative treatments like systemic chemotherapy would be preferred).

Information from the National Library of Medicine

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


Contacts
Contact: Emmanuel M Gabriel, M.D., Ph.D. 904-953-2523 gabriel.emmanuel@mayo.edu
Contact: Michael B Wallace, M.D. 904-953-2221 wallace.michael@mayo.edu

Locations
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    gabriel.emmanuel@mayo.edu   
Principal Investigator: Emmanuel M Gabriel, M.D., Ph. D.         
Sub-Investigator: Michael B Wallace, M.D.         
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Emmanuel M Gabriel, M.D., Ph.D. Mayo Clinic
  Study Documents (Full-Text)

Documents provided by Emmanuel M. Gabriel, Mayo Clinic:
Informed Consent Form  [PDF] January 11, 2019


Publications of Results:

Responsible Party: Emmanuel M. Gabriel, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT03823144     History of Changes
Other Study ID Numbers: 18-010370
First Posted: January 30, 2019    Key Record Dates
Last Update Posted: February 20, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No