RecruitingPhase 3NCT03659448

Performance of SGM-101 for the Delineation of Primary and Recurrent Tumor and Metastases in Patients Undergoing Surgery for Colorectal Cancer

Multicenter, Open-label, Randomized, Controlled, Parallel Arms Clinical Study on Performance of SGM-101, a Fluorochrome-labeled Anti-CEA Monoclonal Antibody, for Delineation of Primary/Recurrent Tumor and Metastases in Patients Undergoing Surgery for Colorectal Cancer


Sponsor

Surgimab

Enrollment

300 participants

Start Date

Jun 17, 2019

Study Type

INTERVENTIONAL

Conditions

Summary

The performance of SGM-101, an intraoperative imaging agent, will be compared to that of standard "white light" visualization during surgical resections of colorectal cancer.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a special dye (called SGM-101) that lights up colorectal cancer cells during surgery, helping surgeons see the boundaries of tumors and any cancer that may have spread to the belly lining more clearly than the naked eye alone. **You may be eligible if...** - You are scheduled for surgery to treat colorectal cancer (either a large primary tumor, a recurrent cancer, or cancer that has spread to the lining of the abdomen) - You are a woman past menopause, or a woman who has had a procedure to prevent pregnancy, or a woman who tests negative for pregnancy before the injection **You may NOT be eligible if...** - You are pregnant or breastfeeding - You have a known allergy to the dye or its components - You are not scheduled for surgery - You have certain other conditions that make receiving the dye unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSGM-101

A fluorochrome-labeled anti-carcinoembryonic antigen (CEA) monoclonal antibody intraoperative imaging agent.


Locations(11)

City of Hope National Medical Center

Duarte, California, United States

Moores Cancer Center - UCSD Health

La Jolla, California, United States

Cleveland Clinic Florida

Weston, Florida, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

University of Massachusetts

Worcester, Massachusetts, United States

Perelman Center for Advanced Medicine

Philadelphia, Pennsylvania, United States

Universitätsmedizin Göttingen, Klinik für Allgemein- Viszeral- und Kinderchirurgie

Göttingen, Germany

Fondazione IRCCS Policlinico San Matteo

Pavia, Lombardy, Italy

Catharina Ziekenhuis Eindhoven

Eindhoven, Netherlands

Leiden University Medical Center

Leiden, Netherlands

Erasmus MC

Rotterdam, Netherlands

View Full Details on ClinicalTrials.gov

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NCT03659448


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