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

NCT03659448 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2024-04-24

No results posted yet for this study

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.

Conditions

  • Colorectal Neoplasms

Interventions

DRUG

SGM-101

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

Sponsors & Collaborators

  • Surgimab

    lead INDUSTRY

Principal Investigators

  • Alex L. Vahrmeijer,, MD, PhD · Leiden University Medical Center, Leiden, The Netherlands

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-17
Primary Completion
2024-11-30
Completion
2024-12-31
FDA Drug
Yes

Countries

  • United States
  • Germany
  • Italy
  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03659448 on ClinicalTrials.gov