A Study of Intravital Microscopy (IVM) in Human Solid Tumors
Tab Title Description
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
- Jacksonville, Florida: 18-010370
NCT ID: NCT03823144
Sponsor Protocol Number: 18-010370
About this study
The purpose of this study is to determine the feasibility of performing HIVM in patients with deep space solid tumors during standard course of surgical resection.
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
- Age ≥ 18 years of age.
- ECOG Performance Status of ≤ 2.
- Measurable tumor by direct visualization requiring surgical resection in the OR.
- Tumor types of origin include gastric, pancreatic, hepatobiliary, colorectal, and sarcoma. Tumors may be primary or metastatic to solid or hollow intra-abdominal organs.
- 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.
- 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 GFR < 45.
- Liver dysfunction as defined by Child-Pugh score > 5, or LFT's 1.5x 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 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 surgery as the standard of care (e.g. high disease burden where alternative treatments like systemic chemotherapy would be preferred).
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Eligibility last updated 6/22/23. Questions regarding updates should be directed to the study team contact.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
|Mayo Clinic Location
Mayo Clinic principal investigator
Emmanuel Gabriel, M.D., Ph.D.
Open for enrollment
Cancer Center Clinical Trials Referral Office
Publications are currently not available