NCT03823144 Intravital Microscopy in Human Solid Tumors
| NCT ID | NCT03823144 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Mayo Clinic |
| Condition | Solid Tumor, Adult |
| Study Type | INTERVENTIONAL |
| Enrollment | 85 participants |
| Start Date | 2019-02-28 |
| Primary Completion | 2027-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 85 participants in total. It began in 2019-02-28 with a primary completion date of 2027-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: * Age ≥ 18 years of age * Eastern Cooperative Oncology Group (ECOG)Performance Status of ≤ 2 * Measurable tumor by direct visualization requiring surgical resection in the operating room (OR) * Tumor types of origin include gastric, pancreatic, hepatobiliary, colorectal, sarcoma, brain, or breast cancer that may involve the axillary lymph nodes cancers. Tumors may be primary or metastatic * Subject must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent * 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: * 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 * Renal dysfunction as defined as a glomerular filtration rate (GFR) \< 45 * Liver dysfunction as defined by Child-Pugh score \> 5, or liver function test (LFT)'s 1.5 x above normal range * Any known allergy or prior reaction to fluorescein or a positive skin prick test to fluorescein * Pregnant or nursing female subjects, determined preoperatively with a urine pregnancy test * Unwilling or unable to follow protocol requirements * Any condition which in the investigators' opinion deems the patient unsuitable (e.g., abnormal electrocardiography \[EKG\], 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) * Any condition that excludes surgical resection as the standard of care for the patient
Contact & Investigator
Emmanuel M Gabriel, M.D., Ph.D.
PRINCIPAL INVESTIGATOR
Mayo Clinic
Frequently Asked Questions
Who can join the NCT03823144 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Solid Tumor, Adult. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03823144 currently recruiting?
Yes, NCT03823144 is actively recruiting participants. Contact the research team at gabriel.emmanuel@mayo.edu for enrollment information.
Where is the NCT03823144 trial being conducted?
This trial is being conducted at Jacksonville, United States.
Who is sponsoring the NCT03823144 clinical trial?
NCT03823144 is sponsored by Mayo Clinic. The principal investigator is Emmanuel M Gabriel, M.D., Ph.D. at Mayo Clinic. The trial plans to enroll 85 participants.