Clinical trial NCT03823144: Intravital Microscopy in Human Solid Tumors
Official title: Intravital Microscopy (IVM) in Human Solid Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Solid Tumor, Adult
Clinical Stage IV Gastric Cancer AJCC v8
Gastric Carcinoma
Malignant Solid Neoplasm
Metastatic Colorectal Carcinoma
Metastatic Gastric Carcinoma
Metastatic Primary Malignant Brain Neoplasm
Metastatic Sarcoma
Postneoadjuvant Therapy Stage IV Gastric Cancer AJCC v8
Resectable Colorectal Carcinoma
Resectable Liver and Intrahepatic Bile Duct Carcinoma
Resectable Pancreatic Carcinoma
Resectable Sarcoma
Stage IV Colorectal Cancer AJCC v8
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2019-01-30
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Detailed description: 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.

Eligibility 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).

Primary outcomes:
measure: 1. Tumor vessel identification (# tumor vessels visualized per high power field)
timeFrame: 12-15 minutes
measure: 2. Tumor vessel density (# tumor vessels per square cm area observed)
timeFrame: 12-15 minutes
measure: 3. Fluorescent dye uptake (# tumor vessels with fluorescent dye uptake and # tumor vessels without dye uptake)
timeFrame: 12-15 minutes
measure: 4. Tumor blood flow (velocity, mm/sec)
timeFrame: 12-15 minutes
Secondary outcomes:
measure: 5. Post-operative comparison of the microvasculature of tumor with normal tissue
timeFrame: 15-20 minutes
measure: 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).
timeFrame: 5-7 days
measure: Post-operative correlation of the microscopic observation of the tumor microvasculature tumor-specific and overall survival.
timeFrame: 5 years
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic Florida
state: Florida
Study officials:
affiliation: Mayo Clinic
name: Emmanuel M Gabriel, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
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