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

Who is this study for? Patients with primary/recurrent tumor and metastases undergoing surgery for colorectal cancer
What treatments are being studied? SGM-101
Status: Recruiting
Location: See all (10) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: No
View:

• Patients should be scheduled for curative colorectal cancer surgery of primary cT4 colon cancer or primary cT3/4 rectal cancer, recurrent colorectal cancer or peritoneal metastasized colorectal cancer.

• Female patients must be of non-child-bearing potential (i.e., women with functioning ovaries who have a documented tubal ligation or hysterectomy, ovariectomy or women who are post-menopausal). Women of child-bearing potential will be included provided that they have a negative urine pregnancy test at the day of the injection and agree to practice adequate contraception for 30 days prior to administration of investigational product, and 30 days after completion of injection.

Locations
United States
California
Moores Cancer Center - UCSD Health
Recruiting
La Jolla
Florida
Cleveland Clinic Florida
Recruiting
Weston
Massachusetts
Massachusetts General Hospital
Not yet recruiting
Boston
University of Massachusetts
Recruiting
Worcester
Pennsylvania
Perelman Center for Advanced Medicine
Recruiting
Philadelphia
Other Locations
Germany
Universitätsmedizin Göttingen, Klinik für Allgemein- Viszeral- und Kinderchirurgie
Recruiting
Göttingen
Italy
Fondazione IRCCS Policlinico San Matteo
Recruiting
Pavia
Netherlands
Catharina Ziekenhuis Eindhoven
Recruiting
Eindhoven
Leiden University Medical Center
Recruiting
Leiden
Erasmus MC
Recruiting
Rotterdam
Contact Information
Primary
John Warner, JD, MPA
johna.warner@outlook.com
8123257657
Backup
Françoise Cailler, PhD
fcailler@surgimab.com
+33 467 798 381
Time Frame
Start Date: June 17, 2019
Estimated Completion Date: December 2023
Participants
Target number of participants: 300
Treatments
Active Comparator: Treatment
Patients will receive a single dose of the study drug, SGM-101, and subsequently undergo surgical resections under both standard white light conditions and then NIR.
No Intervention: No Treatment
Patients will not be administered the study drug, SGM-101, and will undergo surgical resections under standard :white light conditions only.
Related Therapeutic Areas
Sponsors
Leads: Surgimab

This content was sourced from clinicaltrials.gov

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