Spots Global Cancer Trial Database for Performance of SGM-101 for the Delineation of Primary and Recurrent Tumor and Metastases in Patients Undergoing Surgery for Colorectal Cancer
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Trial Identification
Brief Title: Performance of SGM-101 for the Delineation of Primary and Recurrent Tumor and Metastases in Patients Undergoing Surgery for Colorectal Cancer
Official Title: 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
Study ID: NCT03659448
Conditions
Interventions
Study Description
Brief 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.
Detailed Description: The performance of SGM-101, a fluorochrome-labeled anti-carcinoembryonic antigen (CEA) monoclonal antibody intraoperative imaging agent for the delineation of primary and recurrent tumor and metastases in patients undergoing curative surgery for colorectal cancer will be compared to that of standard "white light" visualization in a multicenter, open-label, randomized, controlled, parallel arms clinical study.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
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, Lombardia, Italy
Catharina Ziekenhuis Eindhoven, Eindhoven, , Netherlands
Leiden University Medical Center, Leiden, , Netherlands
Erasmus MC, Rotterdam, , Netherlands
Contact Details
Name: Alex L. Vahrmeijer,, MD, PhD
Affiliation: Leiden University Medical Center, Leiden, The Netherlands
Role: PRINCIPAL_INVESTIGATOR
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