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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
300
A fluorochrome-labeled anti-carcinoembryonic antigen (CEA) monoclonal antibody intraoperative imaging agent.
City of Hope National Medical Center
Duarte, California, United States
RECRUITINGMoores Cancer Center - UCSD Health
La Jolla, California, United States
RECRUITINGSurgical resection histopathology.
Comparison of surgical resections using histopathology as standard of truth..
Time frame: Through completion of surgery, up to 9 weeks.
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Cleveland Clinic Florida
Weston, Florida, United States
RECRUITINGMassachusetts General Hospital
Boston, Massachusetts, United States
NOT_YET_RECRUITINGUniversity of Massachusetts
Worcester, Massachusetts, United States
RECRUITINGPerelman Center for Advanced Medicine
Philadelphia, Pennsylvania, United States
RECRUITINGUniversitätsmedizin Göttingen, Klinik für Allgemein- Viszeral- und Kinderchirurgie
Göttingen, Germany
RECRUITINGFondazione IRCCS Policlinico San Matteo
Pavia, Lombardy, Italy
RECRUITINGCatharina Ziekenhuis Eindhoven
Eindhoven, Netherlands
RECRUITINGLeiden University Medical Center
Leiden, Netherlands
RECRUITING...and 1 more locations