NCT03659448

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Surgimab · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Colorectal Neoplasms

Interventions

Type	Name	Description
DRUG	SGM-101	A fluorochrome-labeled anti-carcinoembryonic antigen (CEA) monoclonal antibody intraoperative imaging agent.

Timeline

• Start date: 2019-06-17
• Primary completion: 2024-11-01
• Completion: 2024-12-01
• First posted: 2018-09-06
• Last updated: 2024-04-24

Locations

11 sites across 4 countries: United States, Germany, Italy, Netherlands

Regulatory

• FDA-regulated drug study