Intravital Microscopy for Cancer

Overseen By Emmanuel M Gabriel, M.D., Ph.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Disqualifiers: Infection, Heart failure, Angina, Arrhythmia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

85 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the blood vessels around solid tumors using intravital microscopy, a tool that allows real-time observation of these vessels. Researchers aim to determine if a patient's tumor vessels can handle systemic therapy, which travels through the bloodstream. The trial targets individuals requiring surgical removal of a solid tumor, such as those in the stomach, pancreas, liver, colon, or breast. Participants must have a tumor visible and measurable during surgery and must pass a skin test for allergies to a dye used in the study. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could enhance future cancer treatments.

Do I need to stop my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that intravital microscopy is safe for visualizing tumor-associated vasculature?

Research has shown that human intravital microscopy (HIVM) is a safe and well-tolerated technique. Studies have found that using HIVM in patients with solid tumors, such as those in the abdomen or certain types of muscle tumors, is feasible and doesn't cause significant harm. These studies have reported no major negative effects, indicating that the procedure is generally safe for patients. It's important to note that this procedure is used to observe blood vessels in real-time during surgery and is not a drug or a traditional treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Human Intravital Microscopy (HIVM) for cancer because it offers a new way to observe tumors in real-time during surgery. Unlike traditional imaging techniques like CT scans or MRIs, which provide static images, HIVM allows doctors to see live, dynamic processes within the tumor. This could help in understanding how cancer cells behave and respond to treatment, potentially leading to more precise surgical interventions. By providing detailed insights into the tumor environment at the cellular level, HIVM might pave the way for personalized cancer treatments in the future.

What evidence suggests that intravital microscopy is effective for visualizing tumor-associated vasculature?

Research has shown that intravital microscopy (IVM) provides important insights into blood vessels in solid tumors. Studies have found that IVM effectively reveals how these blood vessels function. This information helps doctors assess whether a patient's tumor might respond well to certain treatments. Although IVM is not a treatment, it aids doctors in selecting the best therapies by demonstrating how well the tumor's blood vessels can deliver treatment drugs. Overall, it is a promising tool for enhancing personalized cancer care. ^{1 2 4 5 6}

Who Is on the Research Team?

Emmanuel M Gabriel, M.D., Ph.D.

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

ECOG Performance Status of ≤ 2.

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.

Exclusion 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.

Renal dysfunction as defined as a GFR < 45.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgical Resection and IVM

Participants undergo surgical resection and intravital microscopy (IVM) to visualize tumor-associated vasculature

1 day

1 visit (in-person)

Post-operative Observation

Post-operative correlation of microvasculature with pathologic features and comparison with normal tissue

5-7 days

Follow-up

Participants are monitored for safety and effectiveness after surgery

2-3 weeks

1 visit (in-person)

Long-term Follow-up

Correlation of microscopic observations with tumor-specific and overall survival

5 years

What Are the Treatments Tested in This Trial?

Interventions

• Human Intravital Microscopy

Trial Overview 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.

How Is the Trial Designed?

Group I: Arm 1 Experimental Treatment 2 Interventions

Determine the feasibility and clinical utility of performing Human Intravital Microscopy (HIVM) in patients with solid tumors during surgical resection.

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7584984/

Intravital Microscopy (IVM) in Human Solid Tumors This pilot clinical trial will elucidate the physical and functional characteristics of vessels associated with solid tumors.

2. nature.com nature.com/articles/s41598-021-84430-3

A pilot trial of intravital microscopy in the study of the tumor ... The primary outcome was HIVM feasibility to measure vessel characteristics. We secondarily evaluated associations between HIVM vessel ...

3. npcf.us npcf.us/clinical-trials/intravital-microscopy-in-human-solid-tumors/

Intravital Microscopy In Human Solid Tumors This study will investigate the tumor-associated vasculature of patients with solid tumors. The investigators will use a technology known as intravital ...

4. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1002/ctd2.70051

Intravital microscopy contribution to cancer: From ... However, its response rates largely vary (5%‒80%), based on the disease setting and drug choices, and showed suboptimal effects for certain ...

5. trials.teamjackfoundation.org trials.teamjackfoundation.org/trials/NCT03823144

Intravital Microscopy in Human Solid Tumors ... - Clinical Trial Finder PRIMARY OBJECTIVE: I. To determine the feasibility of performing human intravital microscopy (HIVM) in patients with deep space solid tumors during standard ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10130404/

Human intravital microscopy in the study of sarcomas Our prior studies have demonstrated the feasibility of real-time, human intravital microscopy in the study of these tumor types.