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Intravital Microscopy for Peritoneal Carcinomatosis

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 associated with tumors in patients with peritoneal carcinomatosis. The goal is to see if these vessels can be treated with systemic therapy.

Who is the study for?

This trial is for adults over 18 with peritoneal carcinomatosis, visible tumors in the abdomen, and a decent performance status. They must not have severe illnesses like heart failure or liver dysfunction, no allergies to fluorescein, and not be pregnant. Participants need to understand the study's experimental nature.Check my eligibility

What is being tested?

The study uses intravital microscopy (IVM) to observe tumor-associated blood vessels in real-time within the abdominal lining of patients. It aims to assess if these vessels can effectively receive systemic therapy.See study design

What are the potential side effects?

Since IVM is an imaging technique rather than a drug treatment, side effects are minimal but may include discomfort or minor reactions at the visualization site.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Fluorescent dye uptake (# tumor vessels with fluorescent dye uptake and # tumor vessels without dye uptake)

Tumor blood flow (velocity, mm/sec)

Tumor vessel density (# tumor vessels per square cm area observed)

+1 more

Secondary outcome measures

Post-operative comparison of the microvasculature of peritoneal carcinomatosis with normal tissue (peritoneum)

Microvascular Angina

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).

Trial Design

1Treatment groups

Experimental Treatment

Group I: Arm 1Experimental Treatment1 Intervention

Determine the feasibility and clinical utility of performing Human Intravital Microscopy (HIVM) in patients with peritoneal carcinomatosis during standard course of treatment (cytoreductive surgery with hyperthermic intraperitoneal chemotherapy, or CRS-HIPEC).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Human Intravital Microscopy

2018

N/A

~30

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor

3,205 Previous Clinical Trials

3,766,754 Total Patients Enrolled

Emmanuel M Gabriel, M.D., Ph.D.Principal InvestigatorMayo Clinic

1 Previous Clinical Trials

41 Total Patients Enrolled

Media Library

Human Intravital Microscopy Clinical Trial Eligibility Overview. Trial Name: NCT03517852 — N/A

Peritoneal Carcinomatosis Research Study Groups: Arm 1

Peritoneal Carcinomatosis Clinical Trial 2023: Human Intravital Microscopy Highlights & Side Effects. Trial Name: NCT03517852 — N/A

Human Intravital Microscopy 2023 Treatment Timeline for Medical Study. Trial Name: NCT03517852 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any unfilled slots available for individuals to join this trial?

"Clinicaltrials.gov has reported that this study, which was originally published on August 15th 2018 and last revised on January 31st 2022, is not presently enrolling patients. However, there are 2510 alternate clinical trials accepting participants at present."

Answered by AI

Recent research and studies

Nature Reviews CancerJournal

Dissecting Tumour Pathophysiology Using Intravital Microscopy

Jain, Rakesh K., Lance L. Munn, and Dai Fukumura. 2002. “Dissecting Tumour Pathophysiology Using Intravital Microscopy”. Nature Reviews Cancer. Springer Science and Business Media LLC. doi:10.1038/nrc778.

Methods in Molecular BiologyJournal

Intravital Fluorescence Microscopic Molecular Imaging of Atherosclerosis

Jaffer, Farouc A.. 2010. “Intravital Fluorescence Microscopic Molecular Imaging of Atherosclerosis”. Methods in Molecular Biology. Humana Press. doi:10.1007/978-1-60761-901-7_9.

Seminars in Thrombosis and HemostasisJournal

Heterogeneity of the Tumor Vasculature

Nagy, Janice, Sung-Hee Chang, Shou-Ching Shih, Ann Dvorak, and Harold Dvorak. 2010. “Heterogeneity of the Tumor Vasculature”. Seminars in Thrombosis and Hemostasis. Georg Thieme Verlag KG. doi:10.1055/s-0030-1253454.

MicrocirculationJournal