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Intravital Microscopy for Cancer
N/A
Waitlist Available
Led By Emmanuel M Gabriel, M.D., Ph.D.
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
Study Summary
This trial will study the blood vessels in and around solid tumors in order to learn how best to treat them.
Who is the study for?
This trial is for adults over 18 with solid tumors visible and requiring surgical removal, including gastric, pancreatic, hepatobiliary, colorectal, or sarcoma. Participants must have an ECOG Performance Status of ≤2 (able to care for themselves), no severe illnesses like heart failure or infections, normal liver function tests, and not be allergic to fluorescein.Check my eligibility
What is being tested?
The study uses intravital microscopy (IVM) to observe blood vessels in real-time within solid tumors during surgery. It aims to see if the tumor's blood vessels are suitable for systemic therapy based on their functionality.See study design
What are the potential side effects?
Potential side effects may include reactions related to the IVM procedure such as discomfort at the imaging site or sensitivity reactions due to fluorescein used during the process.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
1. Tumor vessel identification (# tumor vessels visualized per high power field)
2. Tumor vessel density (# tumor vessels per square cm area observed)
3. Fluorescent dye uptake (# tumor vessels with fluorescent dye uptake and # tumor vessels without dye uptake)
+1 moreSecondary outcome measures
5. Post-operative comparison of the microvasculature of tumor with normal tissue
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).
Post-operative correlation of the microscopic observation of the tumor microvasculature tumor-specific and overall survival.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Arm 1Experimental Treatment2 Interventions
Determine the feasibility and clinical utility of performing Human Intravital Microscopy (HIVM) in patients with solid tumors during surgical resection.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Diagnostic Microscopy
2017
Completed Early Phase 1
~90
Fluorescein Sodium Injection
2017
Completed Early Phase 1
~90
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Who is running the clinical trial?
Mayo ClinicLead Sponsor
3,206 Previous Clinical Trials
3,767,042 Total Patients Enrolled
Emmanuel M Gabriel, M.D., Ph.D.Principal InvestigatorMayo Clinic
1 Previous Clinical Trials
30 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a medical condition that is not currently under control, such as an active infection, heart failure, unstable chest pain, irregular heartbeats, or a mental health condition that affects your daily life.Your medical condition is too severe for surgery to be a safe option, and other treatments like chemotherapy would be more appropriate.You have a tumor that can be seen and measured during surgery.The trial is for people with cancer that started in the stomach, pancreas, liver, bile ducts, colon or soft tissues. It can be cancer that has spread to other organs in the abdomen.
Research Study Groups:
This trial has the following groups:- Group 1: Arm 1
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this trial actively seeking new participants?
"Indeed, clinicaltrials.gov hosts information that indicates the ongoing recruitment of participants for this trial which was initially posted on February 28th 2019 and last modified on April 4th 2022. The research is searching to enroll 50 individuals across a single site."
Answered by AI
How many individuals are being monitored for this investigation?
"Affirmative. The information hosted on clinicaltrials.gov attests to the active recruitment of this trial, which was initially posted in February 2019 and updated lastly in April 2022. Currently, 50 patients are being sought after at a solitary site."
Answered by AI
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