Performance of SGM-101 for the Delineation of Primary and Recurrent Tumor and Metastases in Patients Undergoing Surgery for Colorectal Cancer
Start Date
6/17/2019
Completion Date
12/1/2024
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 Criteria
Age Range: 18 years to No maximum
Interventions
SGM-101
Conditions
Locations
City of Hope National Medical Center
Duarte, California 91010
United States
Moores Cancer Center - UCSD Health
La Jolla, California 92093
United States
Cleveland Clinic Florida
Weston, Florida 33331
United States
Massachusetts General Hospital
Boston, Massachusetts 02114
United States
University of Massachusetts
Worcester, Massachusetts 01655
United States
Perelman Center for Advanced Medicine
Philadelphia, Pennsylvania 19104
United States
Universitätsmedizin Göttingen, Klinik für Allgemein- Viszeral- und Kinderchirurgie
Göttingen, 37075
Germany
Fondazione IRCCS Policlinico San Matteo
Pavia, Lombardy 27100
Italy
Catharina Ziekenhuis Eindhoven
Eindhoven,
Netherlands
Leiden University Medical Center
Leiden, 2333 CL
Netherlands
Erasmus MC
Rotterdam, 3015
Netherlands